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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
14
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.
Pellegrin University Hospital
Bordeaux, France
Grenoble Alpes University Hospital
Grenoble, France
Lille University Hospital
Lille, France
Hôpital Hôtel-Dieu - APHP
Paris, France
Effectiveness of the URGOnight device on the severity of insomnia
Assessed by the Insomnia Severity Index (ISI) score
Time frame: Change from Baseline ISI score at 4 months of treatment
Adherence to therapy
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
Time frame: During the 4 months of treatment
Acceptability assessed through the motivation of the subject
Motivation to do the exercises evaluated by a Visual Analog Scale (VAS)
Time frame: Visit 3 (Day 100)
Ease of use perceived by the user
Evaluation by a satisfaction questionnaire: comfort, aesthetics, practicality, ...
Time frame: Visit 3 (Day 100)
Learning to control the neurofeedback task
Measurement of the amplitude in µV² of SMR activity in baseline and during exercises
Time frame: Up to 4 months of treatment
Performance during neurofeedback exercises
Progression of URGOnight neurofeedback training scores calculated by the application
Time frame: Up to 4 months of treatment
Effect of the URGOnight device on subjective sleep efficiency (WASO)
Wake After Sleep Onset (WASO) determined by sleep diary
Time frame: V0 (Day 0), V2 (Day 65) and V4 (Day 114)
Effect of the URGOnight device on subjective sleep efficiency (SOL)
Sleep Onset Latency (SOL) determined by sleep diary
Time frame: V0 (Day 0), V2 (Day 65) and V4 (Day 114)
Effect of the URGOnight device on subjective sleep efficiency (TST)
Total Sleep Time (TST) determined by sleep diary
Time frame: V0 (Day 0), V2 (Day 65) and V4 (Day 114)
Effect of the URGOnight device on subjective sleep efficiency (SE)
Sleep efficiency (SE) determined by sleep diary
Time frame: V0 (Day 0), V2 (Day 65) and V4 (Day 114)
Effect of the URGOnight device on objective sleep efficiency (WASO)
Wake After Sleep Onset (WASO) determined by polysomnography
Time frame: V1 (Day 2) and V5 (Day 116)
Effect of the URGOnight device on objective sleep efficiency (SOL)
Sleep Onset Latency (SOL) determined by polysomnography
Time frame: V1 (Day 2) and V5 (Day 116)
Effect of the URGOnight device on objective sleep efficiency (TST)
Total Sleep Time (TST) determined by polysomnography
Time frame: V1 (Day 2) and V5 (Day 116)
Effect of the URGOnight device on objective sleep efficiency (SE)
Sleep efficiency (SE) determined by polysomnography
Time frame: V1 (Day 2) and V5 (Day 116)
Effect of the URGOnight device on objective sleep efficiency (Sleep fragmentation index)
Sleep fragmentation index determined by polysomnography
Time frame: V1 (Day 2) and V5 (Day 116)
Increase in sleep satisfaction
Sleep questionnaire in the application (overall score)
Time frame: Up to 4 months of treatment
Progression of the sleep hygiene
Sleep hygiene questionnaire in the application (overall score)
Time frame: Up to 4 months of treatment
Effect of the URGOnight device on quality of life (Daytime sleepiness)
Epworth Sleepiness Scale (ESS) questionnaire
Time frame: V0 (Day 0) and V5 (Day 116)
Effect of the URGOnight device on quality of life (Overall perceived improvement)
Patient global Impression of Improvement (PGI-I) questionnaire
Time frame: Visit 5 (Day 116)
Maintaining of sleep improvement
Insomnia Severity Index (ISI) questionnaire
Time frame: V6 (6-month follow-up visit) and V7 (9-month follow-up visit)
Effect of the URGOnight device on sleep and wakefulness physiology (resting EEG)
Resting electroencephalographic (EEG) test (10-20 min)
Time frame: V1 (Day 2) and V5 (Day 116)
Effect of the URGOnight device on sleep physiology (density of sleep zones)
Density of sleep zones by polysomnography
Time frame: V1 (Day 2) and V5 (Day 116)
Effect of the URGOnight device on sleep physiology (amplitude of sleep zones)
Amplitude of sleep zones by polysomnography
Time frame: V1 (Day 2) and V5 (Day 116)
Effect of the URGOnight device on sleep physiology (time spent in each sleep stages)
Percentage of time spent in each sleep stage determined by polysomnography
Time frame: V1 (Day 2) and V5 (Day 116)
Effect of the URGOnight device on wakefulness physiology (time spent in each sleep stages)
Percentage of time spent in each sleep stage determined by polysomnography
Time frame: V1 (Day 2) and V5 (Day 116)
Effect of the device on memory
McNair Self-Questionnaire
Time frame: V1 (Day 2), V2 (Day 65) and V5 (Day 116)
Effect of the device on anxiety
State-Trait Anxiety Inventory Y-A Form (STAI-YA)
Time frame: V1 (Day 2), V2 (Day 65) and V5 (Day 116)
Device safety
Collection of Adverse Events
Time frame: Through study completion (an average of 10 months)
Strategies used to get the exercises done
Collection of the strategy employed (in the application)
Time frame: Up to 4 months of treatment
Sub-group analysis of all judging criteria based on chronotype
HORNE and OBSERG Circadian Typology Questionnaire
Time frame: Visit 1 (Day 2)
Sub-group analysis of all judging criteria based on level of control over technology
KUT (One-Dimensional Target Neutral) Locus of Control Questionnaire
Time frame: Visit 1 (Day 2)
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