Clinical trial NCT04777799: Effectiveness and Acceptability of a Digital Solution to Train Specific EEG Frequencies With Neurofeedback for Improving Sleep
Official title: Effectiveness and Acceptability of a Digital Solution to Train Specific EEG Frequencies With Neurofeedback for Improving Sleep
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Insomnia
Sleep Disorder
Keywords: Insomnia
Neurofeedback
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: Urgotech
name: University Hospital, Grenoble
First posted: 2021-03-02
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Interventional, prospective, open-labelled, multicenter, French study
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Effectiveness of the URGOnight device on the severity of insomnia
timeFrame: Change from Baseline ISI score at 4 months of treatment
Secondary outcomes:
measure: Adherence to therapy
timeFrame: During the 4 months of treatment
measure: Acceptability assessed through the motivation of the subject
timeFrame: Visit 3 (Day 100)
measure: Ease of use perceived by the user
timeFrame: Visit 3 (Day 100)
measure: Learning to control the neurofeedback task
timeFrame: Up to 4 months of treatment
measure: Performance during neurofeedback exercises
timeFrame: Up to 4 months of treatment
measure: Effect of the URGOnight device on subjective sleep efficiency (WASO)
timeFrame: V0 (Day 0), V2 (Day 65) and V4 (Day 114)
measure: Effect of the URGOnight device on subjective sleep efficiency (SOL)
timeFrame: V0 (Day 0), V2 (Day 65) and V4 (Day 114)
measure: Effect of the URGOnight device on subjective sleep efficiency (TST)
timeFrame: V0 (Day 0), V2 (Day 65) and V4 (Day 114)
measure: Effect of the URGOnight device on subjective sleep efficiency (SE)
timeFrame: V0 (Day 0), V2 (Day 65) and V4 (Day 114)
measure: Effect of the URGOnight device on objective sleep efficiency (WASO)
timeFrame: V1 (Day 2) and V5 (Day 116)
measure: Effect of the URGOnight device on objective sleep efficiency (SOL)
timeFrame: V1 (Day 2) and V5 (Day 116)
measure: Effect of the URGOnight device on objective sleep efficiency (TST)
timeFrame: V1 (Day 2) and V5 (Day 116)
measure: Effect of the URGOnight device on objective sleep efficiency (SE)
timeFrame: V1 (Day 2) and V5 (Day 116)
measure: Effect of the URGOnight device on objective sleep efficiency (Sleep fragmentation index)
timeFrame: V1 (Day 2) and V5 (Day 116)
measure: Increase in sleep satisfaction
timeFrame: Up to 4 months of treatment
measure: Progression of the sleep hygiene
timeFrame: Up to 4 months of treatment
measure: Effect of the URGOnight device on quality of life (Daytime sleepiness)
timeFrame: V0 (Day 0) and V5 (Day 116)
measure: Effect of the URGOnight device on quality of life (Overall perceived improvement)
timeFrame: Visit 5 (Day 116)
measure: Maintaining of sleep improvement
timeFrame: V6 (6-month follow-up visit) and V7 (9-month follow-up visit)
measure: Effect of the URGOnight device on sleep and wakefulness physiology (resting EEG)
timeFrame: V1 (Day 2) and V5 (Day 116)
measure: Effect of the URGOnight device on sleep physiology (density of sleep zones)
timeFrame: V1 (Day 2) and V5 (Day 116)
measure: Effect of the URGOnight device on sleep physiology (amplitude of sleep zones)
timeFrame: V1 (Day 2) and V5 (Day 116)
measure: Effect of the URGOnight device on sleep physiology (time spent in each sleep stages)
timeFrame: V1 (Day 2) and V5 (Day 116)
measure: Effect of the URGOnight device on wakefulness physiology (time spent in each sleep stages)
timeFrame: V1 (Day 2) and V5 (Day 116)
measure: Effect of the device on memory
timeFrame: V1 (Day 2), V2 (Day 65) and V5 (Day 116)
measure: Effect of the device on anxiety
timeFrame: V1 (Day 2), V2 (Day 65) and V5 (Day 116)
measure: Device safety
timeFrame: Through study completion (an average of 10 months)
measure: Strategies used to get the exercises done
timeFrame: Up to 4 months of treatment
measure: Sub-group analysis of all judging criteria based on chronotype
timeFrame: Visit 1 (Day 2)
measure: Sub-group analysis of all judging criteria based on level of control over technology
timeFrame: Visit 1 (Day 2)
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Pellegrin University Hospital
city: Grenoble
country: France
facility: Grenoble Alpes University Hospital
city: Lille
country: France
facility: Lille University Hospital
city: Paris
country: France
facility: Hôpital Hôtel-Dieu - APHP
Study officials:
References: