WO2020172448A1 - Méthodes non pharmaceutiques d'atténuation des symptômes de sevrage des dépendances - Google Patents

Méthodes non pharmaceutiques d'atténuation des symptômes de sevrage des dépendances Download PDF

Info

Publication number
WO2020172448A1
WO2020172448A1 PCT/US2020/019091 US2020019091W WO2020172448A1 WO 2020172448 A1 WO2020172448 A1 WO 2020172448A1 US 2020019091 W US2020019091 W US 2020019091W WO 2020172448 A1 WO2020172448 A1 WO 2020172448A1
Authority
WO
WIPO (PCT)
Prior art keywords
stimuli
pattern
stimuli pattern
auditory
user
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/US2020/019091
Other languages
English (en)
Inventor
Richard Hanbury
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Sana Health Inc
Original Assignee
Sana Health Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US16/422,592 external-priority patent/US11141559B2/en
Priority claimed from US16/459,318 external-priority patent/US11298502B2/en
Application filed by Sana Health Inc filed Critical Sana Health Inc
Priority to EA202192166A priority Critical patent/EA202192166A1/ru
Priority to MX2021010040A priority patent/MX2021010040A/es
Priority to AU2020226753A priority patent/AU2020226753A1/en
Publication of WO2020172448A1 publication Critical patent/WO2020172448A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M21/00—Other devices or methods to cause a change in the state of consciousness; Devices for producing or ending sleep by mechanical, optical, or acoustical means, e.g. for hypnosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/316—Modalities, i.e. specific diagnostic methods
    • A61B5/369—Electroencephalography [EEG]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/316—Modalities, i.e. specific diagnostic methods
    • A61B5/389—Electromyography [EMG]
    • A61B5/395—Details of stimulation, e.g. nerve stimulation to elicit EMG response
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/316—Modalities, i.e. specific diagnostic methods
    • A61B5/398—Electrooculography [EOG], e.g. detecting nystagmus; Electroretinography [ERG]
    • H—ELECTRICITY
    • H04—ELECTRIC COMMUNICATION TECHNIQUE
    • H04R—LOUDSPEAKERS, MICROPHONES, GRAMOPHONE PICK-UPS OR LIKE ACOUSTIC ELECTROMECHANICAL TRANSDUCERS; ELECTRIC HEARING AIDS; PUBLIC ADDRESS SYSTEMS
    • H04R5/00—Stereophonic arrangements
    • H04R5/033—Headphones for stereophonic communication
    • H—ELECTRICITY
    • H04—ELECTRIC COMMUNICATION TECHNIQUE
    • H04R—LOUDSPEAKERS, MICROPHONES, GRAMOPHONE PICK-UPS OR LIKE ACOUSTIC ELECTROMECHANICAL TRANSDUCERS; ELECTRIC HEARING AIDS; PUBLIC ADDRESS SYSTEMS
    • H04R5/00—Stereophonic arrangements
    • H04R5/04—Circuit arrangements, e.g. for selective connection of amplifier inputs/outputs to loudspeakers, for loudspeaker detection, or for adaptation of settings to personal preferences or hearing impairments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/01—Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording for evaluating the cardiovascular system, e.g. pulse, heart rate, blood pressure or blood flow
    • A61B5/0205—Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording for evaluating the cardiovascular system, e.g. pulse, heart rate, blood pressure or blood flow
    • A61B5/021—Measuring pressure in heart or blood vessels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording for evaluating the cardiovascular system, e.g. pulse, heart rate, blood pressure or blood flow
    • A61B5/024—Measuring pulse rate or heart rate
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording for evaluating the cardiovascular system, e.g. pulse, heart rate, blood pressure or blood flow
    • A61B5/024—Measuring pulse rate or heart rate
    • A61B5/02405—Determining heart rate variability
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
    • A61B5/14542—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue for measuring blood gases
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/16—Devices for psychotechnics; Testing reaction times ; Devices for evaluating the psychological state
    • A61B5/165—Evaluating the state of mind, e.g. depression, anxiety
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/48—Other medical applications
    • A61B5/4806—Sleep evaluation
    • A61B5/4809—Sleep detection, i.e. determining whether a subject is asleep or not
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/48—Other medical applications
    • A61B5/4836—Diagnosis combined with treatment in closed-loop systems or methods
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/6802—Sensor mounted on worn items
    • A61B5/6803—Head-worn items, e.g. helmets, masks, headphones or goggles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M21/00—Other devices or methods to cause a change in the state of consciousness; Devices for producing or ending sleep by mechanical, optical, or acoustical means, e.g. for hypnosis
    • A61M2021/0005—Other devices or methods to cause a change in the state of consciousness; Devices for producing or ending sleep by mechanical, optical, or acoustical means, e.g. for hypnosis by the use of a particular sense, or stimulus
    • A61M2021/0022—Other devices or methods to cause a change in the state of consciousness; Devices for producing or ending sleep by mechanical, optical, or acoustical means, e.g. for hypnosis by the use of a particular sense, or stimulus by the tactile sense, e.g. vibrations
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M21/00—Other devices or methods to cause a change in the state of consciousness; Devices for producing or ending sleep by mechanical, optical, or acoustical means, e.g. for hypnosis
    • A61M2021/0005—Other devices or methods to cause a change in the state of consciousness; Devices for producing or ending sleep by mechanical, optical, or acoustical means, e.g. for hypnosis by the use of a particular sense, or stimulus
    • A61M2021/0027—Other devices or methods to cause a change in the state of consciousness; Devices for producing or ending sleep by mechanical, optical, or acoustical means, e.g. for hypnosis by the use of a particular sense, or stimulus by the hearing sense
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M21/00—Other devices or methods to cause a change in the state of consciousness; Devices for producing or ending sleep by mechanical, optical, or acoustical means, e.g. for hypnosis
    • A61M2021/0005—Other devices or methods to cause a change in the state of consciousness; Devices for producing or ending sleep by mechanical, optical, or acoustical means, e.g. for hypnosis by the use of a particular sense, or stimulus
    • A61M2021/0044—Other devices or methods to cause a change in the state of consciousness; Devices for producing or ending sleep by mechanical, optical, or acoustical means, e.g. for hypnosis by the use of a particular sense, or stimulus by the sight sense
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M21/00—Other devices or methods to cause a change in the state of consciousness; Devices for producing or ending sleep by mechanical, optical, or acoustical means, e.g. for hypnosis
    • A61M21/02—Other devices or methods to cause a change in the state of consciousness; Devices for producing or ending sleep by mechanical, optical, or acoustical means, e.g. for hypnosis for inducing sleep or relaxation, e.g. by direct nerve stimulation, hypnosis, analgesia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3306—Optical measuring means
    • A61M2205/3313—Optical measuring means used specific wavelengths
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3317—Electromagnetic, inductive or dielectric measuring means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/332—Force measuring means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3368—Temperature
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/50—General characteristics of the apparatus with microprocessors or computers
    • A61M2205/52—General characteristics of the apparatus with microprocessors or computers with memories providing a history of measured variating parameters of apparatus or patient
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/587—Lighting arrangements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/06—Head
    • A61M2210/0687—Skull, cranium
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/04—Heartbeat characteristics, e.g. ECG, blood pressure modulation
    • A61M2230/06—Heartbeat rate only
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/08—Other bio-electrical signals
    • A61M2230/10—Electroencephalographic signals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/18—Rapid eye-movements [REM]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/20—Blood composition characteristics
    • A61M2230/205—Blood composition characteristics partial oxygen pressure (P-O2)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/30—Blood pressure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/50—Temperature
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/60—Muscle strain, i.e. measured on the user
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/63—Motion, e.g. physical activity
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/65—Impedance, e.g. conductivity, capacity
    • G—PHYSICS
    • G02—OPTICS
    • G02C—SPECTACLES; SUNGLASSES OR GOGGLES INSOFAR AS THEY HAVE THE SAME FEATURES AS SPECTACLES; CONTACT LENSES
    • G02C5/00—Constructions of non-optical parts
    • G02C5/001—Constructions of non-optical parts specially adapted for particular purposes, not otherwise provided for or not fully classifiable according to technical characteristics, e.g. therapeutic glasses
    • H—ELECTRICITY
    • H04—ELECTRIC COMMUNICATION TECHNIQUE
    • H04R—LOUDSPEAKERS, MICROPHONES, GRAMOPHONE PICK-UPS OR LIKE ACOUSTIC ELECTROMECHANICAL TRANSDUCERS; ELECTRIC HEARING AIDS; PUBLIC ADDRESS SYSTEMS
    • H04R2460/00—Details of hearing devices, i.e. of ear- or headphones covered by H04R1/10 or H04R5/033 but not provided for in any of their subgroups, or of hearing aids covered by H04R25/00 but not provided for in any of its subgroups
    • H04R2460/13—Hearing devices using bone conduction transducers

Definitions

  • the present invention generally relates to assisting those attempting to eliminate addictions, and more particularly to a non-pharmaceutical method of mitigating addictive substance withdrawal symptoms.
  • Addictive substances can cause a physical dependence that is usually difficult to overcome and results in a tolerance that requires higher doses over time. It may be extremely difficult for a person to stop taking a substance to which there are addictive. In particular, the human body responds to an abrupt discontinuation or decrease in intake of addictive substances with withdrawal symptoms. Withdrawal symptoms from opiates include anxiety, sweating, vomiting, and diarrhea. Alcohol withdrawal symptoms include irritability, fatigue, shaking, sweating, and nausea. Withdrawal from nicotine can cause irritability, fatigue, insomnia, headache, and difficulty concentrating. Many prescription and legal nonprescription substances can also cause withdrawal symptoms when individuals stop consuming them, even if they were taken as directed by a physician.
  • Opioids are a class of drugs that include the heroin, synthetic opioids such as fentanyl, and pain relievers available legally by prescription, such as oxycodone (OXYCONTIN ® ), hydrocodone (VICODIN ® ), codeine, and morphine.
  • OXYCONTIN ® oxycodone
  • VICODIN ® hydrocodone
  • codeine codeine
  • morphine morphine
  • the present invention overcomes the disadvantages of the prior art by providing a non-pharmaceutical method of treating effects of addiction withdrawal.
  • the method includes administering a therapeutically effective amount of a sensory stimulus to the person, where the sensory stimulus includes one or more of a visual stimuli and an auditory stimuli.
  • the symptoms include anxiety, pain, sleepiness, sweating, tearing of the eyes, running of the nose, goosebumps, shaking, hot flushes, cold flushes, aching bones, aching muscles, restlessness, nausea, vomiting, muscle twitching, stomach cramps, pain, the need to use an opioid, the desire to use an opioid, and sleep disturbances.
  • the apparatus is characterized for being for the production of sensory stimulus, including one or more of a visual stimuli and an auditory stimuli, for the treatment of symptoms resulting addiction withdrawal.
  • the sensory stimulus includes one or more of a visual stimuli and an auditory stimuli.
  • the symptoms include anxiety, sleepiness, sweating, tearing of the eyes, running of the nose, goosebumps, shaking, hot flushes, cold flushes, aching bones, aching muscles, restlessness, nausea, vomiting, muscle twitching, stomach cramps, pain, the need to use an opioid, the desire to use an opioid, and sleep disturbances.
  • the symptoms result opioid addiction.
  • the symptoms result from nicotine addiction.
  • sensory stimulus is provided to a person using devices and methods described in U.S. Patent Application Serial No. 15/360,808 (the ‘808 patent application) and in U.S. Patent Application Serial No. in 15/910,252 (the‘252 patent application).
  • The‘808 and‘252 patent applications are co-owned with the present patent application and are both herein included by way of incorporation in their entirety.
  • FIG. 1 is a schematic diagram of a system that may be used to provide a therapeutic sensory stimulus to a person;
  • FIGS. 2A, 2B, and 2C are a bottom right perspective view, a rear view, and a left view, respectively, and FIG. 3 is an exploded front view of one embodiment of a headset according to the system of FIG. 1;
  • FIG. 4 is a flow chart of an exemplary method for providing therapeutic auditory, visual, and/or tactile stimulus.
  • FIGS. 5, 6, and 7 are tables illustrating several treatment stimulus segments of FIG. 4.
  • Various embodiments described herein are directed to non-pharmaceutical methods of managing pain.
  • the methods include administering a therapeutically effective amount of a sensory stimulus to the person, resulting in a reduction of the person’s perception of pain, and/or an improvement in the person’s tolerance for pain.
  • the sensory stimulus provided to the person as described herein is provided over a period of time and may, in certain embodiments, comprise two or more simultaneous stimuli, such as a visual stimuli and an auditory stimuli.
  • each sensory stimuli may include a temporal sequence of sensory stimuli patterns, such as a sequence of stimuli having different frequencies, and/or a stimuli that alternates between sensory organs, as by alternating between the eyes or ears or the person.
  • the stimulus may include, but is not limited to, one or more of: a visual stimuli to one or both eyes of the person; an auditory stimuli to one or both ears of the person; and/or a tactile stimuli to the skin of the person.
  • FIGURE 1 is a schematic diagram of a system 100 that may be used to provide a therapeutic sensory stimulus to a person.
  • System 100 provides one or more stimuli outputs that a person wearing the system may experience as an auditory stimuli, a visual stimuli, and/or tactile stimuli.
  • system 100 comprises a left light source 110L, a right light source 110R, a left vibration source 120L, a right vibration source 120R, and a controller 130 for independently controlling and coordinating the action of the light and vibration sources.
  • system 100 may be positioned on the head of a user with left light source 110L positioned over the left eye to provide a left visual stimulus, right light source 110R positioned over the right eye to provide a right visual stimulus, left vibration source 120L positioned to provide left ear auditory stimuli, and right vibration source 120R positioned to provide right ear auditory stimuli.
  • left and right light sources 110L, 110R may each comprise light-emitting diodes, an incandescent light source having a wavelength filter, a fluorescent light source, a backlit LCD panel, or other light source configured to provide to the user light at a desired, predetermined wavelength or wavelength range.
  • left and right vibration sources 120L, 120R may each comprise earbuds, miniature speakers, or other vibration sources that can provide auditory stimuli to a user.
  • left and right vibration sources 120L, 120R may comprise bone conduction transducers in the audible frequency range to provide vibrations to the user’s skull bone that is sensed as auditory by the user’s ear.
  • one or more of left and right vibration sources 120L, 120R may also produce vibrations that are sensed as tactile stimuli.
  • controller 130 may provide first signals to bone conduction transducers that vibrate or oscillate at a first frequency that can be interpreted by the user as auditory stimuli and may provide second signals at a second, lower frequency that can be interpreted as a tactile sensation by the user.
  • bone conduction transducers may be adapted to provide both auditory and tactile stimulus to the user.
  • left and right vibration sources 120L, 120R provide output at specific one or more frequencies or a range of frequencies.
  • left and right vibration sources 120L, 120R are separately controlled to provide output at certain times and to not provide output at other times.
  • a vibration source may be programmed to provide an output as an amplitude modulated audio frequency, which may be, for example and without limitation, 141 Hz, 174 Hz, 232 Hz or 256 Hz.
  • the vibration source is the product of an audio frequency and a square wave.
  • left and right vibration sources 120L, 120R provide signals of slightly different frequencies to the left and right ear. This results in a binaural beats effect, wherein the person perceives a sound at a frequency that is the difference between the frequency in the right ear and the frequency in the left ear.
  • a binaural beats effect wherein the person perceives a sound at a frequency that is the difference between the frequency in the right ear and the frequency in the left ear.
  • One skilled in the art may use this effect to provide sound at brain wave frequencies separately from, or in combination with, the other methods described herein.
  • System 100 also includes a sensor assembly 150 that obtains one or more measurements from the user.
  • sensor 150 may include, or is in communication with, a sensor that measures some property or characteristic of the user, including but not limited to, heart rate, heart rate variability, body temperature, or blood pressure, and includes electronics that provide a signal indicative of the measurement to controller 130.
  • the sensors are connected to sensor assembly 150 by wired or wireless connectors.
  • the sensors may include one or more: electrodes for sensing electrical activity in the brain, as in a 2 or 4 lead EEG, a temperature sensor, and/or a heartbeat sensor, or one or more EMG sensors positioned, for example and without limitation, to measure eye movement to ascertain when REM sleep is reached, and/or to measure muscle tone to aid in determining states of relaxation.
  • controller 130 utilizes the signal from sensor assembly 150 to modify the intensity and/or timing of the light and vibration sources.
  • controller 130 includes: an output 131 to provide signals to actuate light sources 110L and 110R, vibration sources 120L and 120R, and any other components that provide sensory input to the user; an input 132 to accept signals from sensor assembly 150; a non-transitory memory 133 for storing programming and data for system 100; a processor 134; and a communications module 135.
  • Memory 133 includes instructions that are accessible to processor 134 for operating the components that provide sensory input to the user, including but not limited to light sources 110L and 110R, vibration sources 120L and 120R, including accepting input provided to input 132 and modifying signals provided to components that provide sensory input to the user, including but not limited to light sources 110L and 110R, vibration sources 120L and 120R.
  • Communications module 135 provides for the transfer of information to or from controller 130 by wired or wireless means.
  • system 100 may also provide tactile stimulus to a user by including a left tactile stimulus source and a right tactile stimulus source (not shown), each of which may be individually controlled and coordinated with the controller 130 to provide tactile stimuli to a user of therapeutic system 100.
  • FIGURES. 2 A, 2B, and 2C are a bottom right perspective view, a rear view, and a left view, respectively, and FIGURE 3 is an exploded front view headset 200, which is generally similar to system 100 except as explicitly noted.
  • Headset 100 includes sensor assembly 150, controller 130, light sources 110L and 110R, and vibration sources 120L and 120R.
  • Sensor assembly 150 also includes a biometric sensor system, such as that which is sold under the name of VALENCELL BENCHMARKTM (Raleigh, NC), that includes an infrared light source and detector, which can be used to detect heart rate using pulse oximetry, an accelerator, and a processing unit.
  • Sensor assembly 150 includes a sensor module circuit board that contains a digital optical detector system. This detector controls the LEDs and converts the optical signals reflected from the user’s skin to digital format and communicates over the internal I2C bus to the PerformTek® processor.
  • the accelerometer is also read via the internal I2C bus for activity signal.
  • controller 130 includes a Nordic Semiconductor ASA (Oslo, Norway) model NRF51822 Multiprotocol BLUETOOTH® low energy/2.4 GHz RF System on Chip, and a VLSI Solution (Tampere, Finland) model VS1000 audio module.
  • ASA National Semiconductor ASA
  • NRF51822 Multiprotocol BLUETOOTH® low energy/2.4 GHz RF System on Chip and a VLSI Solution (Tampere, Finland) model VS1000 audio module.
  • light sources 110L and 110R are Lite-On, Inc. (Milpitas, CA) Bin G3/W2/AU model LTST-020VSKT LEDS.
  • vibration sources 120L and 120R are Basen Technology Co, Ltd model PN: OEM-E170a earbuds.
  • sensor assembly 150 also includes a PerformTek® processor which polls sensor data over the internal I2C bus and converts the raw measurements into data registers of biometric values (i.e. Heart Rate, Cadence, V02) and processes those values further into higher level user assessments (i.e. Calories Burned, Distance, V02 max, fitness level, and the period between heart rate beats (the Heart Rate Interval, or RR Interval)).
  • the PerformTek® processor runs algorithms to convert the raw signals to a register array of biometric values and high-level assessments. These values are available for reading via the UART or I2C firmware interface.
  • sensor module diagnostics such as signal quality, error codes, and serial number ID are available.
  • Sensor assembly 150 further includes control lines for interfacing controller 130 with the PerformTek® processor include a Power On Self-Test (POST), UART or I2C communication interface, and a wake-from- standby line (WAKE).
  • POST Power On Self-Test
  • WAKE wake-from- standby line
  • the host processor can control much of the functionality of the sensor module via a software protocol interface over the UART or I2C interface.
  • sensor assembly 150 determines a current heart rate, and/or an inter-beat R-R interval which is provided to controller 130. In another embodiment, sensor assembly 150 also provides accelerometer data to controller 130.
  • sensor assembly 150 includes one or more EEG sensors, as are known in the field, and provides brain electrical activity measurements to controller 130.
  • sensor assembly 150 includes one or more EMG sensors positioned, for example and without limitation, to measure eye movement to ascertain when REM sleep is reached, and/or to measure muscle tone to aid in determining states of relaxation.
  • EMG sensors as are known in the field, and provides brain electrical activity measurements to controller 130.
  • Headset 200 also includes left and right audio jacks 101L and 101R into which left and right earbuds 120L and 120R, respectively, may be plugged into.
  • stereo headphones (not shown) may be plugged into one of jacks 101L or 101R, where the jacks are appropriately programmed to provide stereo sound to the headphones.
  • FIGURE 4 shows a flow chart of an exemplary method 400 for providing therapeutic auditory, visual, and/or tactile stimulus using, for example and without limitation, one of system 100 or headset 200.
  • a subject having pain, or who wishes to undergo a treatment for managing pain is identified.
  • the subject is provided the therapeutic system or headwear, such as headset 200 as described above, and in step 430, the subject places the headset on their head.
  • headset 200 executes programming 450 provided in controller 130 to provide stimuli to the subject.
  • the programming provides two or more of auditory, visual, and/or tactile stimulus to the subject, and thus, for example, may provide power to activate left light source 110L, right light source 110R, left vibration source 120L and or right vibration source 120R.
  • the programming also includes modifying the auditory, visual, and/or stimuli in response to measurements obtained by sensor assembly 150 and provided to controller 130.
  • the left vibration source 120L and the right vibration source 120R may each comprise bone conduction transducer that may provide both auditory and tactile stimulus.
  • providing two or more of auditory, visual, and/or tactile stimulus concurrently may provide improved therapeutic benefits as compared to providing only one of auditory, visual, or tactile stimulus at one time.
  • the two or more auditory, visual, and/or tactile stimulus may thus combine to provide the improved therapeutic benefits, for example (i.e., the two or more auditory, visual, and/or tactile stimulus may synergize in a way to provide improved results over providing two of the stimuli individually.)
  • Exemplary instructions for providing stimuli may be provided, for example, by programming 450, which includes one or more subroutines.
  • One such subroutine is subroutine 450e, which analyzes measurements obtained from sensor assembly 150 and stores the analyzed measurements in memory 113.
  • Subroutine 450a includes instructions for the simultaneous activation of all active auditory, visual, and/or tactile stimulus sources.
  • the activation of all sources may include the activation of tactile stimulation to run throughout all subsequent auditory and/or visual stimulation.
  • Another exemplary subroutine 450b may include instructions for alternating the left auditory, visual, and/or tactile stimulus sources with the right auditory, visual, and/or tactile stimulus sources (i.e., the left stimuli and right stimuli take turns being active).
  • Another exemplary subroutine 450c may include instructions for alternating the visual sources with the auditory and/or tactile sources (i.e., the visual stimuli and the auditory/tactile stimuli take turns being active).
  • Another exemplary subroutine 450d may include instructions for alternating the left auditory and/or tactile source and the right visual source with the right auditory and/or tactile source and the left visual source (i.e., opposite auditory/tactile stimuli take turns being active).
  • one or more of subroutines 450a, 450b, 450c, or 450d access the analyzed measurements from subroutine 450e and modifies the instructions they provide to the auditory, visual, and/or tactile stimuli depending on real-time or near real time measurements of the user obtained from sensor assembly 150.
  • programming 450 including by not limited to subroutines 450a, 450b, 450c, and 450d, may each be applied one or more times, individually or in combination with one another.
  • the programming may, in addition, provide sequences of output in subroutines 450a, 450b, 450c, and 450d at different frequencies and/or timings.
  • the subroutines may provide output at specific frequencies that change as the subroutine is repeated.
  • the pulses that determine the amplitude modulation above are essentially square waves and thus, as determined by a Fourier analysis, are formed of sinusoidal components at the pulse frequency and at higher harmonics.
  • the signal power in a square wave with a pulse frequency of 4 Hz includes a 63% of the power at 4 Hz, 21% of the power at 12 Hz, 13% of the power at 20, etc., If the square wave does not have equal on and off periods, then the pulse frequency will also contain even-integer harmonic frequencies.
  • subroutine 450a may provide amplitude modulated auditory output to vibration source 120R or 120L at a carrier audio frequency of 256 Hz that is turned on and off, that is it is pulsed, at a pulse frequency of 1 Hz for 2 minutes, or may provide amplitude modulated light output to light source 110R or 110L that produces at a carrier light wavelength 580 nm that is turned on and off, that is it is pulsed at a at a pulse frequency of 1 Hz for 2 minutes.
  • This square pulse auditory or light signal thus generates signals at a frequency of 1 Hz in addition to higher harmonics.
  • the subroutines described herein generate pulses having sinusoidal components that correspond with certain known brain wave frequencies, which are generally accepted as being delta waves (0.1 to 4.0 Hz), theta brain waves (4 to 7 Hz), alpha brain waves (8 to 15 Hz), beta waves (16 to 31 Hz), and gamma brain waves (32 to 100 Hz).
  • certain embodiments include pulse frequencies of from 3.75 Hz to 4.25 Hz (theta brain waves), of from 1.25 Hz to 1.75 Hz (delta waves), and/or from 0.25 Hz and 0.75 Hz (delta waves).
  • the brain may be stimulated in a way that it is forced to communicate between the left and right sides of the brain.
  • This forced communication for example, can allow PTSD memories to be wired to both sides of the brain, thereby stopping undesirable flashbacks. It can also create an enhanced relaxation effect, allowing for deeper relaxation and pain management.
  • system 100 provides a stimulus that includes visual and auditory stimuli over three temporally sequential segments - a first segment where stimuli occurs at a first frequency, followed by a second segment where stimuli occurs at a second frequency, which was followed by a third segment where stimuli occurs at a third frequency.
  • Each time segment included sub-segments of visual and auditory stimuli, where each sub- segment was determined by one of the subroutines described above, for example.
  • the visual stimuli were provided by pulsing light at a wavelength of 580 nm at certain pulse frequencies and by pulsing auditory signals at a frequency of 256 Hz at certain pulse frequencies.
  • a treatment stimulus lasted for 16 minutes, and may be understood by reference to Table 500 in FIGURE 5, Table 600 in FIGURE 6, and Table 700 in FIGURE 7, where Table 500 contains specifications for the first segment (“Segment A”), Table 600 contains specifications for the next, second time segment (“Segment B”), and Table 700 contains specifications for the last time segment (“Segment C”).
  • Table 500 contains specifications for the first segment (“Segment A”)
  • Table 600 contains specifications for the next, second time segment (“Segment B”)
  • Table 700 contains specifications for the last time segment (“Segment C”).
  • Each of the Segments stimuli patterns at a different pulse frequency.
  • Segment A cycles the stimuli through a block of four Segment A stimuli patterns for a total of 2 minutes
  • Segment B cycles the stimuli through a block of four Segment B stimuli patterns for a total of 2 minutes
  • Segment C cycles the stimuli through a block of six Segment C stimuli patterns for a total of 12 minutes.
  • Blocks Cl, C2, C3 and C4 the auditory and light outputs cycle 14 or 15 times between being on for 1 second and then being off for 1 second (that is, a pulse frequency of 0.5 Hz), followed by no output for 1 second.
  • Blocks Al, Bl, and Cl pulse the right and left sides of both the light and auditory together, with all outputs are synchronized to be on or off at the same time, as provided by subroutine 450a.
  • Blocks A2, B2, and C2 synchronize the left side light and auditory output, and the right side light and auditory output to be opposite to one another, as provided by subroutine 450b.
  • Blocks A3, B3, and C3 synchronize both lights together to be opposite to both auditory outputs, as provided by subroutine 450c.
  • Blocks A4, B4, and C4 synchronize the right auditory and light to be opposite to the left auditory and light outputs, as provided by subroutine 450d.
  • subroutine 450e receives measurements from sensor assembly 150 and stores analyzed measurements.
  • sensor assembly 150 provides instantaneous, or nearly instantaneous, measurements from the user.
  • sensor assembly 150 provides a sequence of measurements of beat-to-beat intervals of the heart of the user, that is, the time interval between the last two heart beats, which is also referred to, without limitation, as the RR intervals.
  • Controller 130 then computes and stores values of the heart rate variability (HRV), which is a mathematical representation of the physiological phenomenon of variation in the time interval between heartbeats.
  • HRV heart rate variability
  • a time-domain calculation of RR intervals is used to compute the HRV.
  • the sequence of RR intervals (“RRi”) is accepted from sensor assembly 150 and stored in memory 133.
  • the HRV is calculated as approximated by the root mean square of successive differences between adjacent RRs, or RMSSD.
  • HRV HRV
  • a decrease in HRV is associated with a less relaxed, or stressed, state.
  • a positive ARMSSD indicates that the person is becoming relaxed and that the system is working as intended.
  • a negative ARMSSD indicates that the person is not becoming more relaxed.
  • an indication that the person is relaxed is used to modify the treatment by reducing the treatment time and/or intensity of the stimuli
  • an indication that the person is less relaxed is used to modify the treatment to increase the treatment time and/or the intensity of the stimuli.
  • Kubios HRV software (manufactured by Kuopio, Finland) is used to analyze the RR intervals to provide additional HRV related data.
  • one useful measure for analyzing HRV is the fraction of the power of the HRV signal that occurs in certain frequency ranges.
  • HRV-HFnu one measure which is referred to herein as HRV-HFnu is obtained by taking the Fourier transform of the HRV signal and computing the ratio of the power of the HRV signal from 0.15 to 0.40 Hz (“high frequencies”) to the total power of the HRV signal
  • steps show method 400 of treating a patient in accordance with embodiments
  • a person of ordinary skill in the art will recognize many variations based on the teaching described herein.
  • the steps may be completed in a different order. Steps may be added or deleted. Some of the steps may comprise sub-steps. Many of the steps may be repeated as often as beneficial to the treatment.
  • One or more of the steps of the method 400 may be performed with the circuitry as described herein, for example, circuitry of the controller 130 or the external control unit 130a such as one or more of a processor or logic circuitry such as a central processing unit (CPU) or a programmable array logic for field programmable gate array.
  • the circuitry may be programmed to provide one or more of the steps of the method 400, and the program may comprise program instructions stored on a computer readable memory or programmed steps of the logic circuitry such as the programmable array logic or the field programmable gate array, for example.
  • test subjects were provided with a number of sensory stimuli and their response to the treatment was determined using subjective measures of the effect of withdrawal using questionnaires, mostly in the form of Visual Analog Scale (“VAS”) surveys, that the person completed before, during, and after treatment.
  • VAS Visual Analog Scale
  • SOWS Subjective Opiate Withdrawal Scale
  • the symptoms measured using SOWS includes, the occurrence of: anxiety, sleepiness, sweating, tearing of the eyes, running of the nose, goosebumps, shaking, hot flushes, cold flushes, bones and muscles aching, restlessness, nausea, vomiting, muscle twitching, stomach cramps, and feeling the need of using an opioid. See, for example, https://www.ncbi.nlm.nih.gov/books/NBK143183/bin/annexlO-fm2.pdf;
  • VAS- Anxiety in which subjects rate their perceived level of anxiety as being between“Not at all anxious,” which is assigned a value of zero, and“Very anxious,” which is assigned a value of 10. See, for example, Davey, H. M., Barratt, A. L., Butow, P. N., & Deeks, J. J. (2007). A one-item question with a Likert or Visual Analog Scale adequately measured current anxiety. Journal of clinical epidemiology, 60(4), 356-360; and
  • VAS-Pain in which subjects rate their perceived level of pain as being between“No Pain,” which is assigned a value of zero, and“Worst Pain Imaginable,” which is assigned a value of 10.
  • Patient-Reported Outcomes Measurement Information System of Sleep Disturbance (PROMIS -Disturbance) is an initiative from the National Institutes of Health to standardize the measurement of common physical and mental diseases, disorders, and conditions.
  • the Sleep Disturbance Scale comprises four separate sub-scales: Quality, Refreshing, Problems, and Difficulty Falling Asleep. The items are then added together, and the resulting estimate can be converted to a standardized measure. Higher scores indicate greater levels of sleep disturbance.
  • Headset 200 has been used in a number of studies, for example, to examine the effects on the headset for improving sleep and in relieving pain. During these studies, the inventor discovered that subjects reported that the use of headset 200 lessened the effects of withdrawal from nicotine addiction.
  • PILOT STUDY [0063] A study was conducted on the effectiveness of the inventive method for treating symptoms of opioid addiction withdrawal using a double-blind, randomized, controlled cross over study of 8 subjects (for a total of 16 subject experiences). The subjects were patients of an inpatient treatment program in which they were receiving daily doses of 60-80 mg of methadone. The demographics of the subjects largely mirroring a methadone-maintained population. There was no attrition and all assessments, as described below, were completed as planned per protocol. The protocol provides for the use of device (headset 200) at regularly scheduled intervals, as described below.
  • headset 200 was tested by having each subject undergo two separate treatment regimes.
  • One regime is referred to herein as an“Active Treatment,” in which subjects were provided with sound and light according to the sequences described above.
  • the other regime is referred to herein as a“Sham Treatment,” in which subjects were provided with light and sound using headset 200 which was programmed to provide light and sound at levels that were not therapeutic in nature.
  • headset 200 was programmed to deliver a 232 Hz tone for a short period at the start of 5-minute cycles of the light turning on, then off, then on.
  • the pilot study proceeded as follows. On a first day, each patient received their normal dose of methadone and was provided with a headset 200, along with instructions on its use. The programming of headset 200 was randomly selected to provide the subject with either an Active Treatment or a Sham Treatment, as described above. Baseline scores were collected within 12 hours of taking their methadone, including SOWS, Desire to Use/Need to Use VAS, Anxiety VAS, and Pain VAS scores, and for PROMIS-Disturbance for the night before the first day. During the first day, the subjects used the appropriately programmed headset 200 (either as an Active Treatment or a Sham Treatment) to receive three treatments, at approximately 16:00, 20:00, and 22:00 to 24:00 (prior to bedtime).
  • the “treatment day” subjects were not allowed to take their normal dose of methadone.
  • the subjects used the appropriately programmed headset 200 to receive five Active Treatments or Sham Treatments over an approximately 16-hour awake period, starting at approximately 8:00 am, with the last treatment prior to bedtime (e.g., at approximately 08:00, 12:00, 16:00, 20:00, and 22:00 to 24:00).
  • Table 1 presents the SOWS scores averaged by treatment condition.
  • a SOWS score of 0-10 is mild withdrawal, 11-20 is moderate, and 21+ is severe.
  • the columns of data in Table 1 are: Baseline mean, presenting SOWS score by condition; Treatment, presenting SOWS score on treatment day per subject, then averaging by condition; Treatment(Max), presenting the largest SOWS score on treatment day per subject, then averaging by condition; and
  • Treatment(Max) presenting the largest SOWS score on treatment day per subject, then averaging by condition.
  • follow-Up presenting the mean SOWS score on the day following treatment day per subject, then averaging by condition.
  • Table 1 SOWS by Treatment Condition.
  • headset 200 provided a therapeutically effective amount of a sensory stimulus for treating, during opioid withdrawal, the combination of anxiety, sleepiness, sweating, tearing of the eyes, running of the nose, goosebumps, shaking, hot flushes, cold flushes, bones and muscles aching, restlessness, nausea, vomiting, muscle twitching, stomach cramps, and feeling the need of using an opioid.
  • Table 2 presents the VAS-Anxiety score by treatment condition, where the VAS- Anxiety score is used to rate the intensity of anxiety with higher numbers indicate more adverse outcomes.
  • the columns of data in Table 2 are: Baseline mean, presenting VAS- Anxiety score by condition; Treatment, presenting VAS-Anxiety score on treatment day per subject, then averaging by condition; Treatment(Max), presenting the largest VAS-Anxiety score on treatment day per subject, then averaging by condition; and
  • Treatment(Max) presenting the largest VAS-Anxiety score on treatment day per subject, then averaging by condition
  • follow-Up presenting the mean VAS-Anxiety score on the day following treatment day per subject, then averaging by condition.
  • Table 2 VAS-Anxiety by Treatment Condition.
  • headset 200 provided a therapeutically effective amount of a sensory stimulus for treating anxiety during opioid withdrawal.
  • Table 3 presents the VAS-Need to Use Opioid (or“VAS-N”) scores averaged by treatment condition. Lower scores indicate less need to use, whereas higher scores at the high end indicate a greater need to use.
  • the columns of data in Table 3 are: Baseline mean, presenting VAS-N score by condition; Treatment, presenting VAS-N score on treatment day per subject, then averaging by condition; Treatment(Max), presenting the largest VAS-N score on treatment day per subject, then averaging by condition; and
  • Follow-Up presenting the mean VAS-N score on the day following treatment day per subject, then averaging by condition.
  • Table 3 VAS-N by Treatment Condition.
  • headset 200 provided a therapeutically effective amount of a sensory stimulus for decreasing the need to use an opioid during opioid withdrawal.
  • VAS-D VAS-Desire to Use Opioid
  • the columns of data in Table 4 are: Baseline mean, presenting VAS-D score by condition; Treatment, presenting VAS-D score on treatment day per subject, then averaging by condition; Treatment(Max), presenting the largest VAS-D score on treatment day per subject, then averaging by condition; and
  • Baseline mean presenting VAS-D score by condition
  • Treatment presenting VAS-D score on treatment day per subject, then averaging by condition
  • Treatment(Max) presenting the largest VAS-D score on treatment day per subject, then averaging by condition
  • follow-Up presenting the mean VAS-D score on the day following treatment day per subject, then averaging by condition.
  • Table 4 VAS-D scores by Treatment Condition.
  • headset 200 provided a therapeutically effective amount of a sensory stimulus for decreasing the desire to use an opioid during opioid withdrawal.
  • Table 5 presents the VAS-Pain scores averaged by treatment condition. Lower scores indicate less desire to use, whereas higher scores at the high end indicate a greater desire to use.
  • the columns of data in Table 5 are: Baseline mean, presenting VAS-Pain score by condition; Treatment, presenting VAS-Pain score on treatment day per subject, then averaging by condition; Treatment(Max), presenting the largest VAS-Pain score on treatment day per subject, then averaging by condition; and
  • Treatment(Max) presenting the largest VAS-Pain score on treatment day per subject, then averaging by condition
  • follow-Up presenting the mean VAS-Pain score on the day following treatment day per subject, then averaging by condition.
  • Table 5 VAS-Pain scores by Treatment Condition.
  • headset 200 provided a therapeutically effective amount of a sensory stimulus for decreasing pain during opioid withdrawal.
  • Table 6 presents the PROMIS Sleep Scale Problems (Disturbance) scores averaged by treatment condition. Higher scores indicate greater levels of sleep disturbance.
  • the columns of data in Table 5 are: Baseline mean, presenting Disturbance score by condition; Treatment, presenting Disturbance score on the evening of treatment day per subject, then averaging by condition; and Follow-Up, presenting the mean Disturbance score on the day following treatment day per subject, then averaging by condition.
  • Table 6 PROMIS Sleep Scale Problems (Disturbance) scores by Treatment Condition.
  • headset 200 provided a therapeutically effective amount of a sensory stimulus for improving sleep during opioid withdrawal.
  • the results of the pilot study of the use of headset 200 to treat symptom of opioid withdrawal are: 1) subjects experienced less frequent use of rescue medications when undergoing Active Treatment compared to the Sham Treatment; and 2) SOWS, Desire to Use/Need to Use VAS, Anxiety VAS, Pain VAS and PROMIS-Disturbance scores for Active Treatment all showed improved outcomes relative to Sham Treatments.
  • each of the methods described herein is in the form of a computer program that executes on a processing system, e.g., a one or more processors that are part of a system 100.
  • a processing system e.g., a one or more processors that are part of a system 100.
  • embodiments of the present invention may be embodied as a method, an apparatus such as a special purpose apparatus, an apparatus such as a data processing system, or a carrier medium, e.g., a computer program product.
  • the carrier medium carries one or more computer readable code segments for controlling a processing system to implement a method.
  • aspects of the present invention may take the form of a method, an entirely hardware embodiment, an entirely software embodiment or an embodiment combining software and hardware aspects.
  • the present invention may take the form of carrier medium (e.g., a computer program product on a computer-readable storage medium) carrying computer- readable program code segments embodied in the medium.
  • carrier medium e.g., a computer program product on a computer-readable storage medium
  • Any suitable computer readable medium may be used including a magnetic storage device such as a diskette or a hard disk, or an optical storage device such as a CD-ROM.
  • a method of treating effects of addiction withdrawal comprising administering a therapeutically effective amount of a sensory stimulus to the person, where said sensory stimulus includes one or more of a visual stimuli and an auditory stimuli.
  • Clause 14 The method of any preceding clause, where said first stimuli pattern includes a sinusoidal component that is between 3.75 Hz and 4.25 Hz, is between 1.25 Hz and 1.75 Hz, or is between 0.25 Hz and 0.75 Hz, where said second stimuli pattern includes a sinusoidal component that is between 3.75 Hz and 4.25 Hz, is between 1.25 Hz and 1.75 Hz, or is between 0.25 Hz and 0.75 Hz, and where said third stimuli pattern includes a sinusoidal component that is between 3.75 Hz and 4.25 Hz, is between 1.25 Hz and 1.75 Hz, or is between 0.25 Hz and 0.75 Hz.
  • a first sensory stimuli including simultaneously providing a left visual stimuli pattern to the left eye of the user and a right auditory stimuli pattern to the right side of the head
  • a second sensory stimuli including simultaneously providing a right visual stimuli pattern to the right eye of the user and a left auditory stimuli pattern to the left side of a head of the user
  • one or more of the left auditory stimuli pattern or the right auditory stimuli pattern comprises a sequence of stimuli patterns including the first stimuli pattern, the second stimuli pattern, and the third stimuli pattern.
  • periodically providing a sensory stimuli including simultaneously providing a left visual stimuli pattern to the left eye of the user, a right visual stimuli pattern to the right eye of the user, a left auditory stimuli pattern to the left side of the head, and a right auditory stimuli pattern to the right side of a head of the user.
  • a third sensory stimuli including simultaneously providing a left visual stimuli pattern to the left eye of the user and a left auditory stimuli pattern to the left side of the head
  • a fourth sensory stimuli including simultaneously providing a right visual stimuli pattern to the right eye of the user and a right auditory stimuli pattern to the right side of a head of the user.
  • a fifth sensory stimuli including simultaneously providing a left auditory stimuli pattern to the left side of the head and a right auditory stimuli pattern to the right side of the head, and
  • a sixth sensory stimuli including simultaneously providing a left visual stimuli pattern to the left eye of the user and a right visual stimuli pattern to the right eye of the user.
  • the left auditory stimuli pattern comprises generating the left auditory stimuli pattern with a left bone conduction transducer of the headset
  • the right auditory stimuli pattern comprises generating the left auditory stimuli pattern with a left bone conduction transducer of a headset.
  • one or more of the left visual stimuli pattern or right visual stimuli pattern comprises repeatedly pulsing a light at one or more of a first pulse frequency, a second pulse frequency less than the first pulse frequency, or a third pulse frequency less than the first and second pulse frequencies.
  • Clause 23 The method of any preceding clause, wherein the first pulse frequency is between 3.75 Hz and 4.25 Hz, the second pulse frequency is between 1.25 Hz and 1.75 Hz, and the third pulse frequency is between 0.25 Hz and 0.75 Hz.
  • sequence of stimuli patterns each have a pulse frequency having a pulse period, where a portion of the pulse period includes a stimulus of an auditory frequency of from 240 Hz to 480 Hz.
  • Clause 40 Else of an apparatus, characterized for being for the production of sensory stimulus, including one or more of a visual stimuli and an auditory stimuli, for the treatment of symptoms resulting addiction withdrawal.
  • a first sensory stimuli including simultaneously providing a left visual stimuli pattern to the left eye of the user and a right auditory stimuli pattern to the right side of the head
  • a second sensory stimuli including simultaneously providing a right visual stimuli pattern to the right eye of the user and a left auditory stimuli pattern to the left side of a head of the user
  • one or more of the left auditory stimuli pattern or the right auditory stimuli pattern comprises a sequence of stimuli patterns including the first stimuli pattern, the second stimuli pattern, and the third stimuli pattern.
  • Clause 55 The use of the apparatus of any preceding clause, further comprising: periodically providing a sensory stimuli including simultaneously providing a left visual stimuli pattern to the left eye of the user, a right visual stimuli pattern to the right eye of the user, a left auditory stimuli pattern to the left side of the head, and a right auditory stimuli pattern to the right side of a head of the user.
  • a third sensory stimuli including simultaneously providing a left visual stimuli pattern to the left eye of the user and a left auditory stimuli pattern to the left side of the head
  • a fourth sensory stimuli including simultaneously providing a right visual stimuli pattern to the right eye of the user and a right auditory stimuli pattern to the right side of a head of the user.
  • a fifth sensory stimuli including simultaneously providing a left auditory stimuli pattern to the left side of the head and a right auditory stimuli pattern to the right side of the head, and
  • a sixth sensory stimuli including simultaneously providing a left visual stimuli pattern to the left eye of the user and a right visual stimuli pattern to the right eye of the user.
  • the left auditory stimuli pattern comprises generating the left auditory stimuli pattern with a left bone conduction transducer of the headset
  • the right auditory stimuli pattern comprises generating the left auditory stimuli pattern with a left bone conduction transducer of a headset.
  • Clause 60 The use of the apparatus of any preceding clause, wherein one or more of the left or right auditory stimuli pattern includes an auditory frequency of from 240 Hz to 480 Hz.
  • Clause 61 The use of the apparatus of any preceding clause, wherein one or more of the left visual stimuli pattern or right visual stimuli pattern comprises repeatedly pulsing a light at one or more of a first pulse frequency, a second pulse frequency less than the first pulse frequency, or a third pulse frequency less than the first and second pulse frequencies.
  • Clause 64 The use of the apparatus of any preceding clause, wherein the predetermined time interval is 25-45 seconds.
  • Clause 65 The use of the apparatus of any preceding clause, wherein the sequence of stimuli patterns each have a pulse frequency having a pulse period, where a portion of the pulse period includes a stimulus of an auditory frequency of from 240 Hz to 480 Hz.
  • Clause 70 The use of the apparatus of any preceding clause, where said first stimuli pattern includes a sinusoidal component corresponding to a delta brain wave frequency, a theta brain wave frequency, or an alpha brain wave frequency, and where said second stimuli pattern includes a sinusoidal component corresponding to a delta brain wave frequency, a theta brain wave frequency, or an alpha brain wave frequency.
  • Clause 71 The use of the apparatus of any preceding clause, where said third stimuli pattern includes a sinusoidal component corresponding to a delta brain wave frequency, a theta brain wave frequency, or an alpha brain wave frequency, and where said second stimuli pattern includes a sinusoidal component corresponding to a delta brain wave frequency, a theta brain wave frequency, or an alpha brain wave frequency.
  • Clause 72 The use of the apparatus of any preceding clause, where said apparatus includes a sensor to obtains a state of the user and modifies said sensory stimulus according to the state of the user.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Physics & Mathematics (AREA)
  • Engineering & Computer Science (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Surgery (AREA)
  • Molecular Biology (AREA)
  • Medical Informatics (AREA)
  • Pathology (AREA)
  • Biophysics (AREA)
  • Psychology (AREA)
  • Acoustics & Sound (AREA)
  • Ophthalmology & Optometry (AREA)
  • Psychiatry (AREA)
  • Signal Processing (AREA)
  • Anesthesiology (AREA)
  • Hematology (AREA)
  • Electrotherapy Devices (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

L'invention concerne une méthode non pharmaceutique de traitement des effets du sevrage des dépendances. Le procédé consiste à appliquer sur une personne des stimuli tels que des stimuli visuels et/ou auditifs qui sont envoyés par impulsions à la fréquence de divers types d'ondes cérébrales. La méthode permet de réduire divers symptômes de sevrage, tels que l'anxiété, la somnolence, la transpiration, le larmoiement, l'écoulement nasal, la chaire de poule, l'agitation, les bouffées de chaleur, les frissons, les os douloureux, les muscles endoloris, l'instabilité, les nausées, les vomissements, les contractions musculaires, les crampes d'estomac, la douleur, le besoin d'avoir recours à un opioïde, le désir d'utiliser un opioïde, les troubles du sommeil, et l'utilisation de médicaments de secours.
PCT/US2020/019091 2019-02-21 2020-02-20 Méthodes non pharmaceutiques d'atténuation des symptômes de sevrage des dépendances Ceased WO2020172448A1 (fr)

Priority Applications (3)

Application Number Priority Date Filing Date Title
EA202192166A EA202192166A1 (ru) 2019-07-01 2020-02-20 Нефармацевтические способы ослабления абстинентных симптомов зависимости
MX2021010040A MX2021010040A (es) 2019-02-21 2020-02-20 Metodos no farmaceuticos para mitigar los síntomas de abstinencia de la adicción.
AU2020226753A AU2020226753A1 (en) 2019-02-21 2020-02-20 Non-pharmaceutical methods of mitigating addiction withdrawal symptoms

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
US201962808676P 2019-02-21 2019-02-21
US62/808,676 2019-02-21
US16/422,592 US11141559B2 (en) 2015-11-23 2019-05-24 Methods and systems for providing stimuli to the brain
US16/422,592 2019-05-24
US16/459,318 2019-07-01
US16/459,318 US11298502B2 (en) 2015-11-23 2019-07-01 Non-pharmaceutical methods of mitigating addiction withdrawal symptoms

Publications (1)

Publication Number Publication Date
WO2020172448A1 true WO2020172448A1 (fr) 2020-08-27

Family

ID=72144462

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2020/019091 Ceased WO2020172448A1 (fr) 2019-02-21 2020-02-20 Méthodes non pharmaceutiques d'atténuation des symptômes de sevrage des dépendances

Country Status (3)

Country Link
AU (1) AU2020226753A1 (fr)
MX (1) MX2021010040A (fr)
WO (1) WO2020172448A1 (fr)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11679231B2 (en) 2015-11-23 2023-06-20 Sana Health Inc. Methods and systems for providing stimuli to the brain
US12691247B2 (en) 2015-11-23 2026-07-28 Sana Health Inc. Systems and methods for visual cortex targeting and treatment
US12697459B2 (en) 2015-11-23 2026-08-04 Sana Health, Inc. Systems and methods for electronic patient stimulation and diagnosis

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2012117343A1 (fr) * 2011-03-02 2012-09-07 Koninklijke Philips Electronics N.V. Dispositif et procédé destinés à l'amélioration cognitive d'un utilisateur
US20180250494A1 (en) * 2017-03-02 2018-09-06 Sana Health, Inc. Methods and systems for modulating stimuli to the brain with biosensors
US20190030279A1 (en) * 2008-09-22 2019-01-31 Dawn Nowlin Method of Conditioning a Living Body to Respond Appropriately to Stimuli
WO2019060598A1 (fr) * 2017-09-22 2019-03-28 Theranova, Llc Procédés et dispositifs de traitement et de gestion de l'addiction
US10328236B2 (en) * 2015-11-23 2019-06-25 Sana Health, Inc. Methods and systems for providing stimuli to the brain

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20190030279A1 (en) * 2008-09-22 2019-01-31 Dawn Nowlin Method of Conditioning a Living Body to Respond Appropriately to Stimuli
WO2012117343A1 (fr) * 2011-03-02 2012-09-07 Koninklijke Philips Electronics N.V. Dispositif et procédé destinés à l'amélioration cognitive d'un utilisateur
US10328236B2 (en) * 2015-11-23 2019-06-25 Sana Health, Inc. Methods and systems for providing stimuli to the brain
US20180250494A1 (en) * 2017-03-02 2018-09-06 Sana Health, Inc. Methods and systems for modulating stimuli to the brain with biosensors
WO2019060598A1 (fr) * 2017-09-22 2019-03-28 Theranova, Llc Procédés et dispositifs de traitement et de gestion de l'addiction

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11679231B2 (en) 2015-11-23 2023-06-20 Sana Health Inc. Methods and systems for providing stimuli to the brain
US11701487B2 (en) 2015-11-23 2023-07-18 Sana Health Inc. Methods and systems for providing stimuli to the brain
US12201781B2 (en) 2015-11-23 2025-01-21 Sana Health, Inc. Methods and systems for providing stimuli to the brain
US12691247B2 (en) 2015-11-23 2026-07-28 Sana Health Inc. Systems and methods for visual cortex targeting and treatment
US12697459B2 (en) 2015-11-23 2026-08-04 Sana Health, Inc. Systems and methods for electronic patient stimulation and diagnosis

Also Published As

Publication number Publication date
AU2020226753A1 (en) 2021-09-09
MX2021010040A (es) 2022-01-04

Similar Documents

Publication Publication Date Title
US11298502B2 (en) Non-pharmaceutical methods of mitigating addiction withdrawal symptoms
AU2018226818B2 (en) Methods and systems for modulating stimuli to the brain with biosensors
US9079030B2 (en) Systems and methods for balancing and maintaining the health of the human autonomic nervous system
CA2516093C (fr) Systeme automatise de traitement de l'insomnie
US10328235B2 (en) System and method for the treatment of insomnia
US8512221B2 (en) Automated treatment system for sleep
US12582797B2 (en) Methods and systems for treating anxiety and depression
US12076496B2 (en) Non-pharmaceutical systems and methods of treating the symptoms of fibromyalgia
US20110034756A1 (en) Sleep inducement apparatus
WO2019226656A1 (fr) Procédé non pharmaceutique de gestion de la douleur
US11400252B2 (en) Non-pharmaceutical method of managing pain
AU2020226753A1 (en) Non-pharmaceutical methods of mitigating addiction withdrawal symptoms
US20240416070A1 (en) Non-pharmaceutical systems and methods of treating the symptoms of fibromyalgia
Keller et al. The influence of acoustic and tactile stimulation on vegetative parameters and EEG in persistent vegetative state
EP3654893B1 (fr) Système d'aide à la détection et à la prise en charge précoces de troubles associés à la respiration
US11524135B2 (en) Non-pharmaceutical systems and methods of treating the symptoms of fibromyalgia
CN103547240B (zh) 用于人类自主神经系统的平衡和维持健康的系统和方法
EP4655034A1 (fr) Méthodes et systèmes destinés à fournir une stimulation sensorielle à un cerveau afin de traiter un trouble de stress post-traumatique
Rajagomathi et al. Analysis of brain wave during sleep by stimulating the acupuncture point

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 20759287

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE

ENP Entry into the national phase

Ref document number: 2020226753

Country of ref document: AU

Date of ref document: 20200220

Kind code of ref document: A

122 Ep: pct application non-entry in european phase

Ref document number: 20759287

Country of ref document: EP

Kind code of ref document: A1