Effectiveness and Acceptability of a Digital Solution to Train Specific EEG Frequencies With Neurofeedback for Improving Sleep

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effectiveness and Acceptability of a Digital Solution to Train Specific EEG Frequencies With Neurofeedback for Improving Sleep

Conditions
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Insomnia, Sleep Disorder

Intervention / Treatment
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* Device: URGOnight


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Interventional, prospective, open-labelled, multicenter, French study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: URGOnight<br>Use of the URGOnight neurofeedback training headband and its associated application | Device: URGOnight<br>* URGOnight is a daytime brain training solution (CE marked) aim at improve the quality of sleep. The device consists of an electroencephalographic (EEG) measuring strip connected to a mobile application. The latter is available free of charge on Android and iOS in various mobile application stores (Google Play Store and App Store). URGOnight is a wireless device, it connects via Bluetooth® Low Energy (BLE) to the URGOnight mobile application running on a smartphone. The EEG data is broadcast via a BLE protocol, and the standard Bluetooth® operating distance has a range of 10 meters. To use the URGOnight solution, the user must authorize the application to access his phone's memory to store his usage data and must also authorize the geolocation of his phone to enable BLE connection. This data is not recorded but is necessary for the proper functioning of the solution.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of the URGOnight device on the severity of insomnia | Assessed by the Insomnia Severity Index (ISI) score | Change from Baseline ISI score at 4 months of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to therapy | Average frequency of use greater than or equal to 12 sessions per month and the number of training interruptions of more than 7 days less than 2, combined to report adherence to therapy | During the 4 months of treatment | 
| Acceptability assessed through the motivation of the subject | Motivation to do the exercises evaluated by a Visual Analog Scale (VAS) | Visit 3 (Day 100) | 
| Ease of use perceived by the user | Evaluation by a satisfaction questionnaire: comfort, aesthetics, practicality, ... | Visit 3 (Day 100) | 
| Learning to control the neurofeedback task | Measurement of the amplitude in µV² of SMR activity in baseline and during exercises | Up to 4 months of treatment | 
| Performance during neurofeedback exercises | Progression of URGOnight neurofeedback training scores calculated by the application | Up to 4 months of treatment | 
| Effect of the URGOnight device on subjective sleep efficiency (WASO) | Wake After Sleep Onset (WASO) determined by sleep diary | V0 (Day 0), V2 (Day 65) and V4 (Day 114) | 
| Effect of the URGOnight device on subjective sleep efficiency (SOL) | Sleep Onset Latency (SOL) determined by sleep diary | V0 (Day 0), V2 (Day 65) and V4 (Day 114) | 
| Effect of the URGOnight device on subjective sleep efficiency (TST) | Total Sleep Time (TST) determined by sleep diary | V0 (Day 0), V2 (Day 65) and V4 (Day 114) | 
| Effect of the URGOnight device on subjective sleep efficiency (SE) | Sleep efficiency (SE) determined by sleep diary | V0 (Day 0), V2 (Day 65) and V4 (Day 114) | 
| Effect of the URGOnight device on objective sleep efficiency (WASO) | Wake After Sleep Onset (WASO) determined by polysomnography | V1 (Day 2) and V5 (Day 116) | 
| Effect of the URGOnight device on objective sleep efficiency (SOL) | Sleep Onset Latency (SOL) determined by polysomnography | V1 (Day 2) and V5 (Day 116) | 
| Effect of the URGOnight device on objective sleep efficiency (TST) | Total Sleep Time (TST) determined by polysomnography | V1 (Day 2) and V5 (Day 116) | 
| Effect of the URGOnight device on objective sleep efficiency (SE) | Sleep efficiency (SE) determined by polysomnography | V1 (Day 2) and V5 (Day 116) | 
| Effect of the URGOnight device on objective sleep efficiency (Sleep fragmentation index) | Sleep fragmentation index determined by polysomnography | V1 (Day 2) and V5 (Day 116) | 
| Increase in sleep satisfaction | Sleep questionnaire in the application (overall score) | Up to 4 months of treatment | 
| Progression of the sleep hygiene | Sleep hygiene questionnaire in the application (overall score) | Up to 4 months of treatment | 
| Effect of the URGOnight device on quality of life (Daytime sleepiness) | Epworth Sleepiness Scale (ESS) questionnaire | V0 (Day 0) and V5 (Day 116) | 
| Effect of the URGOnight device on quality of life (Overall perceived improvement) | Patient global Impression of Improvement (PGI-I) questionnaire | Visit 5 (Day 116) | 
| Maintaining of sleep improvement | Insomnia Severity Index (ISI) questionnaire | V6 (6-month follow-up visit) and V7 (9-month follow-up visit) | 
| Effect of the URGOnight device on sleep and wakefulness physiology (resting EEG) | Resting electroencephalographic (EEG) test (10-20 min) | V1 (Day 2) and V5 (Day 116) | 
| Effect of the URGOnight device on sleep physiology (density of sleep zones) | Density of sleep zones by polysomnography | V1 (Day 2) and V5 (Day 116) | 
| Effect of the URGOnight device on sleep physiology (amplitude of sleep zones) | Amplitude of sleep zones by polysomnography | V1 (Day 2) and V5 (Day 116) | 
| Effect of the URGOnight device on sleep physiology (time spent in each sleep stages) | Percentage of time spent in each sleep stage determined by polysomnography | V1 (Day 2) and V5 (Day 116) | 
| Effect of the URGOnight device on wakefulness physiology (time spent in each sleep stages) | Percentage of time spent in each sleep stage determined by polysomnography | V1 (Day 2) and V5 (Day 116) | 
| Effect of the device on memory | McNair Self-Questionnaire | V1 (Day 2), V2 (Day 65) and V5 (Day 116) | 
| Effect of the device on anxiety | State-Trait Anxiety Inventory Y-A Form (STAI-YA) | V1 (Day 2), V2 (Day 65) and V5 (Day 116) | 
| Device safety | Collection of Adverse Events | Through study completion (an average of 10 months) | 
| Strategies used to get the exercises done | Collection of the strategy employed (in the application) | Up to 4 months of treatment | 
| Sub-group analysis of all judging criteria based on chronotype | HORNE and OBSERG Circadian Typology Questionnaire | Visit 1 (Day 2) | 
| Sub-group analysis of all judging criteria based on level of control over technology | KUT (One-Dimensional Target Neutral) Locus of Control Questionnaire | Visit 1 (Day 2) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Insomnia, Neurofeedback