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

NCT04777799 | Terminated

• 2 other identifiers: 38RC19.2022020-A02600-39
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 4

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.

Conditions

Insomnia; Sleep Disorder

Keywords

Insomnia; Neurofeedback

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (30)

• Adherence to therapy

  During the 4 months of treatment

• Acceptability assessed through the motivation of the subject

  Visit 3 (Day 100)

• Ease of use perceived by the user

  Visit 3 (Day 100)

• Learning to control the neurofeedback task

  Up to 4 months of treatment

• Performance during neurofeedback exercises

  Up to 4 months of treatment

Study Arms (1)

URGOnight

EXPERIMENTAL

Use of the URGOnight neurofeedback training headband and its associated application

Device: URGOnight

Interventions

URGOnight 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.

URGOnight

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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
• 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.
• 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

Sponsors & Collaborators

• AdministrateurDRC: lead
• Urgotech: collaborator
• University Hospital, Grenoble: collaborator

Study Sites (4)

Pellegrin University Hospital

Bordeaux, 33000, France

Location

Grenoble Alpes University Hospital

Grenoble, 38000, France

Location

Lille University Hospital

Lille, 59000, France

Location

Hôpital Hôtel-Dieu - APHP

Paris, 75004, France

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Nervous System Diseases; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Pr

Model Details: Interventional, prospective, open-labelled, multicenter, French study

Study Record Dates

• First Submitted: February 2, 2021
• First Posted: March 2, 2021
• Study Start: May 27, 2021
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: January 5, 2024

Record last verified: 2024-01

Locations

FR (4)