Status:
TERMINATED
Effectiveness and Acceptability of a Digital Solution to Train Specific EEG Frequencies With Neurofeedback for Improving Sleep
Lead Sponsor:
AdministrateurDRC
Collaborating Sponsors:
Urgotech
University Hospital, Grenoble
Conditions:
Insomnia
Sleep Disorder
Eligibility:
All Genders
18-70 years
Phase:
NA
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...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 27 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2022
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT04777799
Start Date
May 27 2021
End Date
June 30 2022
Last Update
January 5 2024
Active Locations (4)
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1
Pellegrin University Hospital
Bordeaux, France, 33000
2
Grenoble Alpes University Hospital
Grenoble, France, 38000
3
Lille University Hospital
Lille, France, 59000
4
Hôpital Hôtel-Dieu - APHP
Paris, France, 75004