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

NCT ID: NCT04777799

Last Updated: 2024-01-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-27
• Study Completion Date: 2022-06-30

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.

Conditions

Insomnia; Sleep Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

URGOnight

Use of the URGOnight neurofeedback training headband and its associated application

Group Type: EXPERIMENTAL

URGOnight

Intervention Type: DEVICE

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.

Interventions

URGOnight

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Urgotech

INDUSTRY

Sponsor Role: collaborator

University Hospital, Grenoble

OTHER

Sponsor Role: collaborator

AdministrateurDRC

OTHER

Sponsor Role: lead

Responsible Party

AdministrateurDRC

Pr

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Pellegrin University Hospital

Bordeaux, , France

Grenoble Alpes University Hospital

Grenoble, , France

Lille University Hospital

Lille, , France

Hôpital Hôtel-Dieu - APHP

Paris, , France

Countries

France

Other Identifiers

2020-A02600-39

Identifier Type: OTHER

Identifier Source: secondary_id

38RC19.202

Identifier Type: -

Identifier Source: org_study_id