Effectiveness and Acceptability of a Digital Solution to Train Specific EEG Frequencies With Neurofeedback for Improving Sleep
- Conditions
- Sleep DisorderInsomnia
- Interventions
- Device: URGOnight
- Registration Number
- NCT04777799
- Lead Sponsor
- AdministrateurDRC
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 14
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description URGOnight URGOnight Use of the URGOnight neurofeedback training headband and its associated application
- Primary Outcome Measures
Name Time Method Effectiveness of the URGOnight device on the severity of insomnia Change from Baseline ISI score at 4 months of treatment Assessed by the Insomnia Severity Index (ISI) score
- Secondary Outcome Measures
Name Time Method Adherence to therapy During the 4 months of treatment 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
Effect of the URGOnight device on objective sleep efficiency (SE) V1 (Day 2) and V5 (Day 116) Sleep efficiency (SE) determined by polysomnography
Device safety Through study completion (an average of 10 months) Collection of Adverse Events
Strategies used to get the exercises done Up to 4 months of treatment Collection of the strategy employed (in the application)
Effect of the URGOnight device on subjective sleep efficiency (SOL) V0 (Day 0), V2 (Day 65) and V4 (Day 114) Sleep Onset Latency (SOL) determined by sleep diary
Effect of the URGOnight device on objective sleep efficiency (TST) V1 (Day 2) and V5 (Day 116) Total Sleep Time (TST) determined by polysomnography
Progression of the sleep hygiene Up to 4 months of treatment Sleep hygiene questionnaire in the application (overall score)
Acceptability assessed through the motivation of the subject Visit 3 (Day 100) Motivation to do the exercises evaluated by a Visual Analog Scale (VAS)
Performance during neurofeedback exercises Up to 4 months of treatment Progression of URGOnight neurofeedback training scores calculated by the application
Effect of the URGOnight device on subjective sleep efficiency (WASO) V0 (Day 0), V2 (Day 65) and V4 (Day 114) Wake After Sleep Onset (WASO) determined by sleep diary
Effect of the URGOnight device on subjective sleep efficiency (TST) V0 (Day 0), V2 (Day 65) and V4 (Day 114) Total Sleep Time (TST) determined by sleep diary
Effect of the URGOnight device on objective sleep efficiency (WASO) V1 (Day 2) and V5 (Day 116) Wake After Sleep Onset (WASO) determined by polysomnography
Effect of the URGOnight device on objective sleep efficiency (Sleep fragmentation index) V1 (Day 2) and V5 (Day 116) Sleep fragmentation index determined by polysomnography
Maintaining of sleep improvement V6 (6-month follow-up visit) and V7 (9-month follow-up visit) Insomnia Severity Index (ISI) questionnaire
Ease of use perceived by the user Visit 3 (Day 100) Evaluation by a satisfaction questionnaire: comfort, aesthetics, practicality, ...
Increase in sleep satisfaction Up to 4 months of treatment Sleep questionnaire in the application (overall score)
Effect of the URGOnight device on sleep and wakefulness physiology (resting EEG) V1 (Day 2) and V5 (Day 116) Resting electroencephalographic (EEG) test (10-20 min)
Effect of the URGOnight device on sleep physiology (amplitude of sleep zones) V1 (Day 2) and V5 (Day 116) Amplitude of sleep zones by polysomnography
Effect of the URGOnight device on sleep physiology (time spent in each sleep stages) V1 (Day 2) and V5 (Day 116) Percentage of time spent in each sleep stage determined by polysomnography
Effect of the device on memory V1 (Day 2), V2 (Day 65) and V5 (Day 116) McNair Self-Questionnaire
Sub-group analysis of all judging criteria based on chronotype Visit 1 (Day 2) HORNE and OBSERG Circadian Typology Questionnaire
Learning to control the neurofeedback task Up to 4 months of treatment Measurement of the amplitude in µV² of SMR activity in baseline and during exercises
Effect of the URGOnight device on subjective sleep efficiency (SE) V0 (Day 0), V2 (Day 65) and V4 (Day 114) Sleep efficiency (SE) determined by sleep diary
Effect of the URGOnight device on objective sleep efficiency (SOL) V1 (Day 2) and V5 (Day 116) Sleep Onset Latency (SOL) determined by polysomnography
Effect of the URGOnight device on quality of life (Daytime sleepiness) V0 (Day 0) and V5 (Day 116) Epworth Sleepiness Scale (ESS) questionnaire
Effect of the URGOnight device on sleep physiology (density of sleep zones) V1 (Day 2) and V5 (Day 116) Density of sleep zones by polysomnography
Effect of the URGOnight device on wakefulness physiology (time spent in each sleep stages) V1 (Day 2) and V5 (Day 116) Percentage of time spent in each sleep stage determined by polysomnography
Effect of the device on anxiety V1 (Day 2), V2 (Day 65) and V5 (Day 116) State-Trait Anxiety Inventory Y-A Form (STAI-YA)
Effect of the URGOnight device on quality of life (Overall perceived improvement) Visit 5 (Day 116) Patient global Impression of Improvement (PGI-I) questionnaire
Sub-group analysis of all judging criteria based on level of control over technology Visit 1 (Day 2) KUT (One-Dimensional Target Neutral) Locus of Control Questionnaire
Trial Locations
- Locations (4)
Lille University Hospital
🇫🇷Lille, France
Pellegrin University Hospital
🇫🇷Bordeaux, France
Hôpital Hôtel-Dieu - APHP
🇫🇷Paris, France
Grenoble Alpes University Hospital
🇫🇷Grenoble, France