InsomniaCONNECTOSOMNCT04777799
Effectiveness and Acceptability of a Digital Solution to Train Specific EEG Frequencies With Neurofeedback for Improving Sleep
A study testing URGOnight in people with Insomnia and Sleep Disorder, run by AdministrateurDRC at 4 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Insomnia, Sleep Disorder
- What is being tested?
- URGOnight
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 4 sitesFrance
- Study dates
- 27 May 2021to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
4 sites in 1 country.
France4 sites
Pellegrin University Hospital
Bordeaux, 33000
Grenoble Alpes University Hospital
Grenoble, 38000
Lille University Hospital
Lille, 59000
Hôpital Hôtel-Dieu - APHP
Paris, 75004
About this study
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.
Read the 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.
- Conditions
- Insomnia, Sleep Disorder
- Being tested
- URGOnight
- Keywords
- Insomnia, Neurofeedback
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
URGOnightDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| URGOnight | Experimental | Use of the URGOnight neurofeedback training headband and its associated application Receives: Device: URGOnight |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of the URGOnight device on the severity of insomnia
Assessed by the Insomnia Severity Index (ISI) score
Measured: Change from Baseline ISI score at 4 months of treatment
Secondary outcomes (30)
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
Measured: 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)
Measured: Visit 3 (Day 100)
Ease of use perceived by the user
Evaluation by a satisfaction questionnaire: comfort, aesthetics, practicality, ...
Measured: Visit 3 (Day 100)
Learning to control the neurofeedback task
Measurement of the amplitude in µV² of SMR activity in baseline and during exercises
Measured: Up to 4 months of treatment
Performance during neurofeedback exercises
Progression of URGOnight neurofeedback training scores calculated by the application
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: V1 (Day 2) and V5 (Day 116)
Effect of the URGOnight device on objective sleep efficiency (SOL)
Sleep Onset Latency (SOL) determined by polysomnography
Measured: V1 (Day 2) and V5 (Day 116)
Effect of the URGOnight device on objective sleep efficiency (TST)
Total Sleep Time (TST) determined by polysomnography
Measured: V1 (Day 2) and V5 (Day 116)
Effect of the URGOnight device on objective sleep efficiency (SE)
Sleep efficiency (SE) determined by polysomnography
Measured: 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
Measured: V1 (Day 2) and V5 (Day 116)
Increase in sleep satisfaction
Sleep questionnaire in the application (overall score)
Measured: Up to 4 months of treatment
Progression of the sleep hygiene
Sleep hygiene questionnaire in the application (overall score)
Measured: Up to 4 months of treatment
Effect of the URGOnight device on quality of life (Daytime sleepiness)
Epworth Sleepiness Scale (ESS) questionnaire
Measured: 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
Measured: Visit 5 (Day 116)
Maintaining of sleep improvement
Insomnia Severity Index (ISI) questionnaire
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: V1 (Day 2) and V5 (Day 116)
Effect of the device on memory
McNair Self-Questionnaire
Measured: 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)
Measured: V1 (Day 2), V2 (Day 65) and V5 (Day 116)
Device safety
Collection of Adverse Events
Measured: Through study completion (an average of 10 months)
Strategies used to get the exercises done
Collection of the strategy employed (in the application)
Measured: Up to 4 months of treatment
Sub-group analysis of all judging criteria based on chronotype
HORNE and OBSERG Circadian Typology Questionnaire
Measured: 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
Measured: Visit 1 (Day 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2021
- Study start27 May 2021
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Why it stopped: Decision of the sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Interventional, prospective, open-labelled, multicenter, French study
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- AdministrateurDRC
- Sponsor type
- University, hospital or other
- Collaborators
- Urgotech, University Hospital, Grenoble
- Responsible party
- Sponsor-investigator, AdministrateurDRC, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04777799
- Sponsor's protocol ID
- 38RC19.202
- Other IDs
- 2020-A02600-39
- Acronym
- CONNECTOSOM
- Status last verified
- Jan 2024
- First submitted
- 2 Feb 2021
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Acceptability of a Digital Solution to Train Specific EEG Frequencies With Neurofeedback for Improving Sleep
- ClinicalTrials.gov ID
- NCT04777799
- Acronym / sponsor ID
- CONNECTOSOM / 38RC19.202
- Conditions
- Insomnia, Sleep Disorder
- Keywords
- Insomnia, Neurofeedback
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Decision of the sponsor
- Enrolment
- 14 participants (actual)
- Lead sponsor
- AdministrateurDRCUniversity, hospital or other
- Collaborators
- Urgotech, University Hospital, Grenoble
- Study start
- 27 May 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 2 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Interventional, prospective, open-labelled, multicenter, French study
| Arm | Type | Receives |
|---|---|---|
| URGOnight | Experimental | Device: URGOnightUse of the URGOnight neurofeedback training headband and its associated application |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (18 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| URGOnightURGOnight 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. | Device | URGOnight |
Primary outcome
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
30 secondary outcomes
Adherence to therapy
Time frame: During the 4 months of treatment
Acceptability assessed through the motivation of the subject
Time frame: Visit 3 (Day 100)
Ease of use perceived by the user
Time frame: Visit 3 (Day 100)
Learning to control the neurofeedback task
Time frame: Up to 4 months of treatment
Performance during neurofeedback exercises
Time frame: Up to 4 months of treatment
Effect of the URGOnight device on subjective sleep efficiency (WASO)
Time frame: V0 (Day 0), V2 (Day 65) and V4 (Day 114)
Effect of the URGOnight device on subjective sleep efficiency (SOL)
Time frame: V0 (Day 0), V2 (Day 65) and V4 (Day 114)
Effect of the URGOnight device on subjective sleep efficiency (TST)
Time frame: V0 (Day 0), V2 (Day 65) and V4 (Day 114)
Effect of the URGOnight device on subjective sleep efficiency (SE)
Time frame: V0 (Day 0), V2 (Day 65) and V4 (Day 114)
Effect of the URGOnight device on objective sleep efficiency (WASO)
Time frame: V1 (Day 2) and V5 (Day 116)
Effect of the URGOnight device on objective sleep efficiency (SOL)
Time frame: V1 (Day 2) and V5 (Day 116)
Effect of the URGOnight device on objective sleep efficiency (TST)
Time frame: V1 (Day 2) and V5 (Day 116)
Effect of the URGOnight device on objective sleep efficiency (SE)
Time frame: V1 (Day 2) and V5 (Day 116)
Effect of the URGOnight device on objective sleep efficiency (Sleep fragmentation index)
Time frame: V1 (Day 2) and V5 (Day 116)
Increase in sleep satisfaction
Time frame: Up to 4 months of treatment
Progression of the sleep hygiene
Time frame: Up to 4 months of treatment
Effect of the URGOnight device on quality of life (Daytime sleepiness)
Time frame: V0 (Day 0) and V5 (Day 116)
Effect of the URGOnight device on quality of life (Overall perceived improvement)
Time frame: Visit 5 (Day 116)
Maintaining of sleep improvement
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)
Time frame: V1 (Day 2) and V5 (Day 116)
Effect of the URGOnight device on sleep physiology (density of sleep zones)
Time frame: V1 (Day 2) and V5 (Day 116)
Effect of the URGOnight device on sleep physiology (amplitude of sleep zones)
Time frame: V1 (Day 2) and V5 (Day 116)
Effect of the URGOnight device on sleep physiology (time spent in each sleep stages)
Time frame: V1 (Day 2) and V5 (Day 116)
Effect of the URGOnight device on wakefulness physiology (time spent in each sleep stages)
Time frame: V1 (Day 2) and V5 (Day 116)
Effect of the device on memory
Time frame: V1 (Day 2), V2 (Day 65) and V5 (Day 116)
Effect of the device on anxiety
Time frame: V1 (Day 2), V2 (Day 65) and V5 (Day 116)
Device safety
Time frame: Through study completion (an average of 10 months)
Strategies used to get the exercises done
Time frame: Up to 4 months of treatment
Sub-group analysis of all judging criteria based on chronotype
Time frame: Visit 1 (Day 2)
Sub-group analysis of all judging criteria based on level of control over technology
Time frame: Visit 1 (Day 2)
Results and safety
The study was stopped early (reason given: Decision of the sponsor). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing URGOnight in people with Insomnia and Sleep Disorder, run by AdministrateurDRC at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Decision of the sponsor). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of the URGOnight device on the severity of insomnia (time frame: Change from Baseline ISI score at 4 months of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2024.