Classifications

• • 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]
  • A61B5/372—Analysis of electroencephalograms
  • A61B5/374—Detecting the frequency distribution of signals, e.g. detecting delta, theta, alpha, beta or gamma waves
• • 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
• • 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
  • A61B5/4815—Sleep quality
• • 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
  • A61B5/25—Bioelectric electrodes therefor
  • A61B5/279—Bioelectric electrodes therefor specially adapted for particular uses
  • A61B5/291—Bioelectric electrodes therefor specially adapted for particular uses for 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
  • A61B5/369—Electroencephalography [EEG]
  • A61B5/375—Electroencephalography [EEG] using biofeedback
• • 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
• • 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
  • A61B5/72—Signal processing specially adapted for physiological signals or for diagnostic purposes
  • A61B5/7225—Details of analog processing, e.g. isolation amplifier, gain or sensitivity adjustment, filtering, baseline or drift compensation
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/74—Details of notification to user or communication with user or patient ; user input means
  • A61B5/746—Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms
• • 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
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/48—Other medical applications
  • A61B5/4806—Sleep evaluation
  • A61B5/4812—Detecting sleep stages or cycles
• • 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
  • 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
  • A61M2021/0011—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 in a subliminal way, i.e. below the threshold of sensation
• • 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

Definitions

• the invention relates to a system and method for characterizing the sleep of an individual.
• the present invention is not only for people prone to sleep disorders such as insomnia but more generally to anyone wishing to improve its recovery capacity including during or after an effort, a trip, a stressful situation or something else.
• Sleep spindles are signals of cerebral electrical activity of frequencies generally between 9 and 16 Hz (Molle et al., 2011) and of amplitude ranging from 25 to 150 microvolts. There are sleep spindles of low frequencies and high frequencies, variable and specific to each individual. Sleep spindles usually last between 0.5 to 2 seconds and are the product of reticulo-thalamo cortical network activity.
• Sleep spindles appear during sleep, especially during the light sleep phase (phase called sleep NREM stage N2) (De Gennaro & Ferrara, 2003, De Gennaro, Ferrara, Curcio, & Cristiani, 2001). Indeed, during this phase, we see that they appear in greater numbers. We still distinguish it in deep sleep (phase called N3 stage of sleep) but are more rare or even absent in so-called paradoxical sleep (phase called N4 stage of sleep or REM sleep). Sleep spindles are often referred to as "sleep wardens" and usually a high density of sleep spindles is associated with effective sleep. Conversely, the scientific literature has recently shown that a low density of sleep spindles seems to be a sign of sleep disturbed by stress (Dang-Vu et al., 2015).
• the inventors have thus discovered that sleep spindles, which have a frequency specific to each individual, play an important role during the light sleep phase by their waking inhibitory effect.
• a training of the brain waves emitted by the individual in the awake state and based on frequency intervals of Standardized SMR waves without taking into account any specific frequency range corresponding to sleep spindles specifically emitted by an individual in the asleep state does not allow effective customization of a treatment to a particular individual.
• Such a treatment only allows the stimulation of certain SMR waves whose frequencies do not necessarily correspond to those of the sleeping spindles of said individual in the asleep state.
• This type of training which does not guarantee or at least obtain in a simple and fast way an increase in the density and amplitude of the spindles of sleep, does not offer a satisfactory efficiency on the treatment of disorders especially sleep.
• a measurement device adapted to measure a signal of brain activity representative of the brain waves
• the communication interface can be portable by hand by the individual.
• the CPU may be adapted to modify, i.e., raise or lower, the threshold and / or a time period above the threshold.
• the method of characterization may comprise during the step of identifying the reduced range of sleep spindles, a prior identification of the individual frequency of the individual's alpha peak, defined within a window of frequencies between 7 to 13 Hz.
• the spectral power density of the alpha waves corresponds to the distribution of the amplitude in volt of these waves between the frequencies ranging from 7 to 13 Hz.
• To obtain the signal of the alpha waves one subtract the power spectrum between 7 and 13 Hz, that is to say the amplitude of these waves, obtained in the awake subject having the eyes open to the spectrum of the same individual in the awake state having the eyes closed.
• the individual frequency of the alpha peak thus corresponds to the absolute maximum of the amplitude in this frequency window ranging from 7 to 13 Hz.
• the individual frequency of the peak alpha can be measured (in Hertz), according to another embodiment, by the following calculation: a ratio of the weighted sum of the spectral powers in a frequency window of between 7 and 13 Hz on the spectral power total of the alpha waves in the window, the spectral powers of the weighted sum being weighted by the frequencies of the window:
• FIG. 1 is a representation of a sleep characterization system of an individual, comprising a measuring device in the form of a helmet adapted to measure a cerebral activity signal representative of the brain waves, and a central unit electronics adapted to identify at least a reduced range of individual sleep spindles, and a portable hand-held communication interface for providing a warning signal when a cerebral activity signal parameter in the reduced range of sleep spindles exceeds a threshold,
• FIG. 3 is a representation of the cerebral activity signal representative of the brain waves of the individual acquired by the measuring device of FIG. 1, identifying the reduced range of sleep spindles specific to the individual,
• FIG. 1 shows an embodiment of a user 2 sleep characterization system 1 for use in neurological feedback processing to improve the user's sleep speed and sleep quality 2.
• a measuring device 5 adapted to measure a cerebral activity signal representative of the brain waves of the user's brain 2, and
• the measuring device 5 is in the form of a helmet 6 comprising a support 7, possibly adjustable, intended to be placed on the head of the user 2.
• the cerebral activity signal is measured in the form of a electrical potential difference between one or more reference electrodes 8, a ground electrode 11 and one or more measuring electrodes 9 arranged on the support 7 as appropriate.
• the reference electrodes 8, 9 and mass 11 are preferably dry electrodes.
• the brain activity of each individual is characterized by: - waves emitted in a frequency range between 8 Hz and 13 Hz for one of the individuals identified as subject 1, and in a frequency range between 8 Hz and 12 Hz for the other individual identified as subject 2 ,
• the brain activity of each individual is characterized by sleep spindles or spindles emitted in a reduced range of sleep spindles between 12 Hz and 15 Hz for the subject 1, and in a reduced range of sleep spindles between 13.5 Hz and 16 Hz for subject 2. It appears that the reduced range of sleep spindles, whose waking inhibitory effect plays an important role during the light sleep phase, is specific to each individual.
• the identification of a reduced range of sleep spindles can be performed in the asleep state of the user 2 by detecting, in the 9 to 16 Hz frequency range of the cerebral activity signal during the light sleep phase, brain waves having an amplitude greater than 15 ⁇ and a duration of between 0.5 second and 2 seconds.
• the central unit 21 is then adapted to control the transmission of the audible warning signal in the earphones 10 and the visual warning signal on the screen of the communication interface 22 when the parameter of the cerebral activity signal in the frequency range corresponding to the reduced range of sleep spindles exceeds the threshold, preferably for a specified period of time, such as at least 0.25 seconds.
• the central unit 21 identifies the reduced range of sleep spindles of the user 2.
• This reduced range of sleep spindles includes the brainwave frequencies of the sleeping user having an amplitude greater than 15 ⁇ and a duration of between 0.5 seconds and 2 seconds.
• the audible warning signal is emitted in the 10 and the visual warning signal is displayed via the communication interface 22.
• the communication interface 22 can be adapted to issue any other type of warning signal and in particular , tactile, olfactory or taste.
• the user 2 is thus warned of the emission of brain waves promoting the quality of sleep.

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• Animal Behavior & Ethology (AREA)
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• Power Engineering (AREA)
• Artificial Intelligence (AREA)
• Computer Vision & Pattern Recognition (AREA)
• Measurement And Recording Of Electrical Phenomena And Electrical Characteristics Of The Living Body (AREA)
• Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)

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• 2015
  • 2015-07-07 FR FR1556421A patent/FR3038509B1/fr active Active
• 2016
  • 2016-07-07 US US15/738,316 patent/US11051752B2/en active Active
  • 2016-07-07 JP JP2017567245A patent/JP6913036B2/ja active Active
  • 2016-07-07 EP EP16750933.0A patent/EP3319516A1/de not_active Withdrawn
  • 2016-07-07 WO PCT/FR2016/051730 patent/WO2017006062A1/fr active Application Filing
  • 2016-07-07 CA CA2989986A patent/CA2989986A1/fr not_active Abandoned
  • 2016-07-07 KR KR1020187000295A patent/KR20180026720A/ko not_active Application Discontinuation
  • 2016-07-07 CN CN201680039762.XA patent/CN107847177B/zh active Active

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