Decision of the sponsor

The management of insomnia includes, as a first step, a healthy lifestyle, including physical activity at appropriate times, nutritional monitoring, reduced consumption of stimulants, bedtime and wake-up times that do not vary between weekdays and weekends, banning screens at least two hours before bedtime, etc. If all these conditions are met and insomnia persists, additionnal therapies may be offered. URGOTECH has developed a connected headband allowing to practice neurofeedback in complete autonomy in subjects reporting dissatisfaction with the quality of their sleep.

Among the parameters of brain activity used in neurofeedback, the most frequently used EEG activity is training to strengthen sensorimotor rhythms (SMR). This training could make it possible to reduce cortical hyperstimulation associated with certain sleep disorders. Our hypothesis is that the application of such a neurofeedback technique in an ecological situation at home will improve the subjective quality of their sleep.

The subject must perform, at home, at least 3 sessions per week with the URGOnight solution for about 4 months. Since regularity is important in order to observe effects, subjects are followed up by smartphone application at least 3 times over the training period.

Inclusion Criteria:

• Insomnia according to DSM V criteria (sleep latency greater than or equal to 30 minutes, night-time waking time greater than 30 minutes and early awakening for at least 1 month)
• ISI score greater than or equal to 15
• Head circumference: 52-62 cm
• Subjects not suffering from a characterized depressive episode and/or severe anxiety (Hospital Anxiety and Depression Scale with Depression score<11 and Anxiety score<11)
• Having a smartphone (Android 5 or iOS 11), an internet connection and able to use it
• Able to give free, informed and written consent
• Affiliated or beneficiary of a social security

Exclusion Criteria:

• Organic Sleep Disorders: Sleep Apnea Syndrome, Restless Legs, Narcolepsy, Hypersomnia, Kleine-Levin, Sleep Related Eating Syndrome and Nocturnal Bulimia
• Acute or chronic pathologies incompatible with the study follow-up according to the investigator's assessment (severe psychiatric disorders by MMSE interview, acute pain and acute pain acutization)
• Antidepressants and/or hypnotics whose dosage was changed within 3 months prior to inclusion
• Epilepsy
• Sleep-disturbing environment (noise, newborns, etc.)
• Shift work
• Time difference travel from at least 3 zones more than once a month during the study period
• BMI>30
• Drug use in the 3 months prior to inclusion (including caffeine addiction at investigator's discretion)
• Weekly alcohol consumption of more than 21 glasses for a man and 14 for a woman (without exceeding 4 glasses per day and with at least one alcohol-free evening during the week)
• Use of alcohol to sleep
• Pregnant, parturient or breastfeeding women / Subject deprived of liberty by administrative or judicial decision / Persons under guardianship or curatorship or adults protected by law according to articles L1121-5 to L1121-8
• Subjects not affiliated with social security
• Subject with psychological and/or linguistic incapacity to understand and follow the constraints of the study
• Participation in another interventional clinical study where the intervention may have an impact on the objective and primary endpoint during the 4 weeks prior to the start of the study.
• A person who has participated in another research study with an exclusion period still in progress at the time of inclusion.
• Subject who would receive more than 4500 euros in compensation for participation in other biomedical research in the 12 months prior to this study
• Subject cannot be contacted in case of emergency