Back to resultsEffectiveness and Acceptability of a Digital Solution to Train Specific EEG Frequencies With Neurofeedback for Improving Sleep (CONNECTOSOM)
Primary Purpose
Insomnia, Sleep Disorder
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
URGOnight
Sponsored by
About this trial
This is an interventional other trial for Insomnia focused on measuring Insomnia, Neurofeedback
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
Sites / Locations
- Pellegrin University HospitalRecruiting
- Grenoble Alpes University HospitalRecruiting
- Lille University Hospital
- Hôpital Hôtel-Dieu - APHPRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
URGOnight
Arm Description
Use of the URGOnight neurofeedback training headband and its associated application
Outcomes
Primary Outcome Measures
Effectiveness of the URGOnight device on the severity of insomnia
Assessed by the Insomnia Severity Index (ISI) score
Secondary Outcome Measures
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
Acceptability assessed through the motivation of the subject
Motivation to do the exercises evaluated by a Visual Analog Scale (VAS)
Ease of use perceived by the user
Evaluation by a satisfaction questionnaire: comfort, aesthetics, practicality, ...
Learning to control the neurofeedback task
Measurement of the amplitude in µV² of SMR activity in baseline and during exercises
Performance during neurofeedback exercises
Progression of URGOnight neurofeedback training scores calculated by the application
Effect of the URGOnight device on subjective sleep efficiency (WASO)
Wake After Sleep Onset (WASO) determined by sleep diary
Effect of the URGOnight device on subjective sleep efficiency (SOL)
Sleep Onset Latency (SOL) determined by sleep diary
Effect of the URGOnight device on subjective sleep efficiency (TST)
Total Sleep Time (TST) determined by sleep diary
Effect of the URGOnight device on subjective sleep efficiency (SE)
Sleep efficiency (SE) determined by sleep diary
Effect of the URGOnight device on objective sleep efficiency (WASO)
Wake After Sleep Onset (WASO) determined by polysomnography
Effect of the URGOnight device on objective sleep efficiency (SOL)
Sleep Onset Latency (SOL) determined by polysomnography
Effect of the URGOnight device on objective sleep efficiency (TST)
Total Sleep Time (TST) determined by polysomnography
Effect of the URGOnight device on objective sleep efficiency (SE)
Sleep efficiency (SE) determined by polysomnography
Effect of the URGOnight device on objective sleep efficiency (Sleep fragmentation index)
Sleep fragmentation index determined by polysomnography
Increase in sleep satisfaction
Sleep questionnaire in the application (overall score)
Progression of the sleep hygiene
Sleep hygiene questionnaire in the application (overall score)
Effect of the URGOnight device on quality of life (Daytime sleepiness)
Epworth Sleepiness Scale (ESS) questionnaire
Effect of the URGOnight device on quality of life (Overall perceived improvement)
Patient global Impression of Improvement (PGI-I) questionnaire
Maintaining of sleep improvement
Insomnia Severity Index (ISI) questionnaire
Effect of the URGOnight device on sleep and wakefulness physiology (resting EEG)
Resting electroencephalographic (EEG) test (10-20 min)
Effect of the URGOnight device on sleep physiology (density of sleep zones)
Density of sleep zones by polysomnography
Effect of the URGOnight device on sleep physiology (amplitude of sleep zones)
Amplitude of sleep zones by polysomnography
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
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
Effect of the device on memory
McNair Self-Questionnaire
Effect of the device on anxiety
State-Trait Anxiety Inventory Y-A Form (STAI-YA)
Device safety
Collection of Adverse Events
Strategies used to get the exercises done
Collection of the strategy employed (in the application)
Sub-group analysis of all judging criteria based on chronotype
HORNE and OBSERG Circadian Typology Questionnaire
Sub-group analysis of all judging criteria based on level of control over technology
KUT (One-Dimensional Target Neutral) Locus of Control Questionnaire
Full Information
NCT ID
NCT04777799
First Posted
February 2, 2021
Last Updated
October 13, 2021
Sponsor
URGOTECH
Collaborators
Urgotech, University Hospital, Grenoble
1. Study Identification
Unique Protocol Identification Number
NCT04777799
Brief Title
Effectiveness and Acceptability of a Digital Solution to Train Specific EEG Frequencies With Neurofeedback for Improving Sleep
Acronym
CONNECTOSOM
Official Title
Effectiveness and Acceptability of a Digital Solution to Train Specific EEG Frequencies With Neurofeedback for Improving Sleep
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 27, 2021 (Actual)
Primary Completion Date
May 22, 2022 (Anticipated)
Study Completion Date
August 22, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
URGOTECH
Collaborators
Urgotech, University Hospital, Grenoble
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia, Sleep Disorder
Keywords
Insomnia, Neurofeedback
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Interventional, prospective, open-labelled, multicenter, French study
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
URGOnight
Arm Type
Experimental
Arm Description
Use of the URGOnight neurofeedback training headband and its associated application
Intervention Type
Device
Intervention Name(s)
URGOnight
Intervention Description
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.
Primary Outcome Measure Information:
Title
Effectiveness of the URGOnight device on the severity of insomnia
Description
Assessed by the Insomnia Severity Index (ISI) score
Time Frame
Change from Baseline ISI score at 4 months of treatment
Secondary Outcome Measure Information:
Title
Adherence to therapy
Description
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
Title
Acceptability assessed through the motivation of the subject
Description
Motivation to do the exercises evaluated by a Visual Analog Scale (VAS)
Time Frame
Visit 3 (Day 100)
Title
Ease of use perceived by the user
Description
Evaluation by a satisfaction questionnaire: comfort, aesthetics, practicality, ...
Time Frame
Visit 3 (Day 100)
Title
Learning to control the neurofeedback task
Description
Measurement of the amplitude in µV² of SMR activity in baseline and during exercises
Time Frame
Up to 4 months of treatment
Title
Performance during neurofeedback exercises
Description
Progression of URGOnight neurofeedback training scores calculated by the application
Time Frame
Up to 4 months of treatment
Title
Effect of the URGOnight device on subjective sleep efficiency (WASO)
Description
Wake After Sleep Onset (WASO) determined by sleep diary
Time Frame
V0 (Day 0), V2 (Day 65) and V4 (Day 114)
Title
Effect of the URGOnight device on subjective sleep efficiency (SOL)
Description
Sleep Onset Latency (SOL) determined by sleep diary
Time Frame
V0 (Day 0), V2 (Day 65) and V4 (Day 114)
Title
Effect of the URGOnight device on subjective sleep efficiency (TST)
Description
Total Sleep Time (TST) determined by sleep diary
Time Frame
V0 (Day 0), V2 (Day 65) and V4 (Day 114)
Title
Effect of the URGOnight device on subjective sleep efficiency (SE)
Description
Sleep efficiency (SE) determined by sleep diary
Time Frame
V0 (Day 0), V2 (Day 65) and V4 (Day 114)
Title
Effect of the URGOnight device on objective sleep efficiency (WASO)
Description
Wake After Sleep Onset (WASO) determined by polysomnography
Time Frame
V1 (Day 2) and V5 (Day 116)
Title
Effect of the URGOnight device on objective sleep efficiency (SOL)
Description
Sleep Onset Latency (SOL) determined by polysomnography
Time Frame
V1 (Day 2) and V5 (Day 116)
Title
Effect of the URGOnight device on objective sleep efficiency (TST)
Description
Total Sleep Time (TST) determined by polysomnography
Time Frame
V1 (Day 2) and V5 (Day 116)
Title
Effect of the URGOnight device on objective sleep efficiency (SE)
Description
Sleep efficiency (SE) determined by polysomnography
Time Frame
V1 (Day 2) and V5 (Day 116)
Title
Effect of the URGOnight device on objective sleep efficiency (Sleep fragmentation index)
Description
Sleep fragmentation index determined by polysomnography
Time Frame
V1 (Day 2) and V5 (Day 116)
Title
Increase in sleep satisfaction
Description
Sleep questionnaire in the application (overall score)
Time Frame
Up to 4 months of treatment
Title
Progression of the sleep hygiene
Description
Sleep hygiene questionnaire in the application (overall score)
Time Frame
Up to 4 months of treatment
Title
Effect of the URGOnight device on quality of life (Daytime sleepiness)
Description
Epworth Sleepiness Scale (ESS) questionnaire
Time Frame
V0 (Day 0) and V5 (Day 116)
Title
Effect of the URGOnight device on quality of life (Overall perceived improvement)
Description
Patient global Impression of Improvement (PGI-I) questionnaire
Time Frame
Visit 5 (Day 116)
Title
Maintaining of sleep improvement
Description
Insomnia Severity Index (ISI) questionnaire
Time Frame
V6 (6-month follow-up visit) and V7 (9-month follow-up visit)
Title
Effect of the URGOnight device on sleep and wakefulness physiology (resting EEG)
Description
Resting electroencephalographic (EEG) test (10-20 min)
Time Frame
V1 (Day 2) and V5 (Day 116)
Title
Effect of the URGOnight device on sleep physiology (density of sleep zones)
Description
Density of sleep zones by polysomnography
Time Frame
V1 (Day 2) and V5 (Day 116)
Title
Effect of the URGOnight device on sleep physiology (amplitude of sleep zones)
Description
Amplitude of sleep zones by polysomnography
Time Frame
V1 (Day 2) and V5 (Day 116)
Title
Effect of the URGOnight device on sleep physiology (time spent in each sleep stages)
Description
Percentage of time spent in each sleep stage determined by polysomnography
Time Frame
V1 (Day 2) and V5 (Day 116)
Title
Effect of the URGOnight device on wakefulness physiology (time spent in each sleep stages)
Description
Percentage of time spent in each sleep stage determined by polysomnography
Time Frame
V1 (Day 2) and V5 (Day 116)
Title
Effect of the device on memory
Description
McNair Self-Questionnaire
Time Frame
V1 (Day 2), V2 (Day 65) and V5 (Day 116)
Title
Effect of the device on anxiety
Description
State-Trait Anxiety Inventory Y-A Form (STAI-YA)
Time Frame
V1 (Day 2), V2 (Day 65) and V5 (Day 116)
Title
Device safety
Description
Collection of Adverse Events
Time Frame
Through study completion (an average of 10 months)
Title
Strategies used to get the exercises done
Description
Collection of the strategy employed (in the application)
Time Frame
Up to 4 months of treatment
Title
Sub-group analysis of all judging criteria based on chronotype
Description
HORNE and OBSERG Circadian Typology Questionnaire
Time Frame
Visit 1 (Day 2)
Title
Sub-group analysis of all judging criteria based on level of control over technology
Description
KUT (One-Dimensional Target Neutral) Locus of Control Questionnaire
Time Frame
Visit 1 (Day 2)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-Louis PEPIN, Prof
Phone
0476768354
Ext
+33
Email
jpepin@chu-grenoble.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Emma TOURE CUQ, PhD
Phone
0784570769
Ext
+33
Email
ETOURE@urgotech.fr
Facility Information:
Facility Name
Pellegrin University Hospital
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stéphanie BIOULAC, Dr
Email
stephanie.bioulac@chu-bordeaux.fr
First Name & Middle Initial & Last Name & Degree
Stéphanie BIOULAC, Dr
Facility Name
Grenoble Alpes University Hospital
City
Grenoble
ZIP/Postal Code
38000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Louis PEPIN, Prof.
Email
jpepin@chu-grenoble.fr
First Name & Middle Initial & Last Name & Degree
Robin TERRAIL
Phone
+33476767166
Email
rterrail@chu-grenoble.fr
First Name & Middle Initial & Last Name & Degree
Jean-Louis PEPIN, Prof.
Facility Name
Lille University Hospital
City
Lille
ZIP/Postal Code
59000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isabelle POIROT, Dr
Email
isabelle.poirot@chru-lille.fr
First Name & Middle Initial & Last Name & Degree
Isabelle POIROT, Dr
Facility Name
Hôpital Hôtel-Dieu - APHP
City
Paris
ZIP/Postal Code
75004
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Damien LEGER, Prof
First Name & Middle Initial & Last Name & Degree
Damien LEGER, Prof
12. IPD Sharing Statement
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Effectiveness and Acceptability of a Digital Solution to Train Specific EEG Frequencies With Neurofeedback for Improving Sleep
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