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

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ClinicalTrials.gov Identifier: NCT04777799
Recruitment Status : Recruiting
First Posted : March 2, 2021
Last Update Posted : October 14, 2021
Sponsor:
Collaborators:
Urgotech
University Hospital, Grenoble
Information provided by (Responsible Party):
URGOTECH, University Hospital, Grenoble

Study Description
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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.

Condition or disease Intervention/treatment Phase
Insomnia Sleep Disorder Device: URGOnight Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Interventional, prospective, open-labelled, multicenter, French study
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Effectiveness and Acceptability of a Digital Solution to Train Specific EEG Frequencies With Neurofeedback for Improving Sleep
Actual Study Start Date : May 27, 2021
Estimated Primary Completion Date : May 22, 2022
Estimated Study Completion Date : August 22, 2023
Arms and Interventions
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Arm Intervention/treatment
Experimental: URGOnight
Use of the URGOnight neurofeedback training headband and its associated application
 Device: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Effectiveness of the URGOnight device on the severity of insomnia [ Time Frame: Change from Baseline ISI score at 4 months of treatment ]
    Assessed by the Insomnia Severity Index (ISI) score


Secondary Outcome Measures :
  1. Adherence to therapy [ Time Frame: 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

  2. Acceptability assessed through the motivation of the subject [ Time Frame: Visit 3 (Day 100) ]
    Motivation to do the exercises evaluated by a Visual Analog Scale (VAS)

  3. Ease of use perceived by the user [ Time Frame: Visit 3 (Day 100) ]
    Evaluation by a satisfaction questionnaire: comfort, aesthetics, practicality, ...

  4. Learning to control the neurofeedback task [ Time Frame: Up to 4 months of treatment ]
    Measurement of the amplitude in µV² of SMR activity in baseline and during exercises

  5. Performance during neurofeedback exercises [ Time Frame: Up to 4 months of treatment ]
    Progression of URGOnight neurofeedback training scores calculated by the application

  6. Effect of the URGOnight device on subjective sleep efficiency (WASO) [ Time Frame: V0 (Day 0), V2 (Day 65) and V4 (Day 114) ]
    Wake After Sleep Onset (WASO) determined by sleep diary

  7. Effect of the URGOnight device on subjective sleep efficiency (SOL) [ Time Frame: V0 (Day 0), V2 (Day 65) and V4 (Day 114) ]
    Sleep Onset Latency (SOL) determined by sleep diary

  8. Effect of the URGOnight device on subjective sleep efficiency (TST) [ Time Frame: V0 (Day 0), V2 (Day 65) and V4 (Day 114) ]
    Total Sleep Time (TST) determined by sleep diary

  9. Effect of the URGOnight device on subjective sleep efficiency (SE) [ Time Frame: V0 (Day 0), V2 (Day 65) and V4 (Day 114) ]
    Sleep efficiency (SE) determined by sleep diary

  10. Effect of the URGOnight device on objective sleep efficiency (WASO) [ Time Frame: V1 (Day 2) and V5 (Day 116) ]
    Wake After Sleep Onset (WASO) determined by polysomnography

  11. Effect of the URGOnight device on objective sleep efficiency (SOL) [ Time Frame: V1 (Day 2) and V5 (Day 116) ]
    Sleep Onset Latency (SOL) determined by polysomnography

  12. Effect of the URGOnight device on objective sleep efficiency (TST) [ Time Frame: V1 (Day 2) and V5 (Day 116) ]
    Total Sleep Time (TST) determined by polysomnography

  13. Effect of the URGOnight device on objective sleep efficiency (SE) [ Time Frame: V1 (Day 2) and V5 (Day 116) ]
    Sleep efficiency (SE) determined by polysomnography

  14. Effect of the URGOnight device on objective sleep efficiency (Sleep fragmentation index) [ Time Frame: V1 (Day 2) and V5 (Day 116) ]
    Sleep fragmentation index determined by polysomnography

  15. Increase in sleep satisfaction [ Time Frame: Up to 4 months of treatment ]
    Sleep questionnaire in the application (overall score)

  16. Progression of the sleep hygiene [ Time Frame: Up to 4 months of treatment ]
    Sleep hygiene questionnaire in the application (overall score)

  17. Effect of the URGOnight device on quality of life (Daytime sleepiness) [ Time Frame: V0 (Day 0) and V5 (Day 116) ]
    Epworth Sleepiness Scale (ESS) questionnaire

  18. Effect of the URGOnight device on quality of life (Overall perceived improvement) [ Time Frame: Visit 5 (Day 116) ]
    Patient global Impression of Improvement (PGI-I) questionnaire

  19. Maintaining of sleep improvement [ Time Frame: V6 (6-month follow-up visit) and V7 (9-month follow-up visit) ]
    Insomnia Severity Index (ISI) questionnaire

  20. Effect of the URGOnight device on sleep and wakefulness physiology (resting EEG) [ Time Frame: V1 (Day 2) and V5 (Day 116) ]
    Resting electroencephalographic (EEG) test (10-20 min)

  21. Effect of the URGOnight device on sleep physiology (density of sleep zones) [ Time Frame: V1 (Day 2) and V5 (Day 116) ]
    Density of sleep zones by polysomnography

  22. Effect of the URGOnight device on sleep physiology (amplitude of sleep zones) [ Time Frame: V1 (Day 2) and V5 (Day 116) ]
    Amplitude of sleep zones by polysomnography

  23. Effect of the URGOnight device on sleep physiology (time spent in each sleep stages) [ Time Frame: V1 (Day 2) and V5 (Day 116) ]
    Percentage of time spent in each sleep stage determined by polysomnography

  24. Effect of the URGOnight device on wakefulness physiology (time spent in each sleep stages) [ Time Frame: V1 (Day 2) and V5 (Day 116) ]
    Percentage of time spent in each sleep stage determined by polysomnography

  25. Effect of the device on memory [ Time Frame: V1 (Day 2), V2 (Day 65) and V5 (Day 116) ]
    McNair Self-Questionnaire

  26. Effect of the device on anxiety [ Time Frame: V1 (Day 2), V2 (Day 65) and V5 (Day 116) ]
    State-Trait Anxiety Inventory Y-A Form (STAI-YA)

  27. Device safety [ Time Frame: Through study completion (an average of 10 months) ]
    Collection of Adverse Events

  28. Strategies used to get the exercises done [ Time Frame: Up to 4 months of treatment ]
    Collection of the strategy employed (in the application)

  29. Sub-group analysis of all judging criteria based on chronotype [ Time Frame: Visit 1 (Day 2) ]
    HORNE and OBSERG Circadian Typology Questionnaire

  30. Sub-group analysis of all judging criteria based on level of control over technology [ Time Frame: Visit 1 (Day 2) ]
    KUT (One-Dimensional Target Neutral) Locus of Control Questionnaire


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04777799


Contacts
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Contact: Jean-Louis PEPIN, Prof 0476768354 ext +33 jpepin@chu-grenoble.fr
Contact: Emma TOURE CUQ, PhD 0784570769 ext +33 ETOURE@urgotech.fr

Locations
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France
Pellegrin University Hospital Recruiting
Bordeaux, France, 33000
Contact: Stéphanie BIOULAC, Dr       stephanie.bioulac@chu-bordeaux.fr   
Principal Investigator: Stéphanie BIOULAC, Dr         
Grenoble Alpes University Hospital Recruiting
Grenoble, France, 38000
Contact: Jean-Louis PEPIN, Prof.       jpepin@chu-grenoble.fr   
Contact: Robin TERRAIL    +33476767166    rterrail@chu-grenoble.fr   
Principal Investigator: Jean-Louis PEPIN, Prof.         
Lille University Hospital Not yet recruiting
Lille, France, 59000
Contact: Isabelle POIROT, Dr       isabelle.poirot@chru-lille.fr   
Principal Investigator: Isabelle POIROT, Dr         
Hôpital Hôtel-Dieu - APHP Recruiting
Paris, France, 75004
Contact: Damien LEGER, Prof         
Principal Investigator: Damien LEGER, Prof         
Sponsors and Collaborators
URGOTECH
Urgotech
University Hospital, Grenoble
More Information
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Responsible Party: URGOTECH, Pr. Jean-Louis PEPIN, University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT04777799    
Other Study ID Numbers: 38RC19.202
2020-A02600-39 ( Other Identifier: ID/RCB )
First Posted: March 2, 2021    Key Record Dates
Last Update Posted: October 14, 2021
Last Verified: October 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by URGOTECH, University Hospital, Grenoble:
Insomnia
Neurofeedback
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Sleep Wake Disorders
Sleep Disorders, Intrinsic
Dyssomnias
 Nervous System Diseases
Mental Disorders
Neurologic Manifestations