Disorders of Excessive SomnolenceREWINDNCT07120061
Test-retest Reliability of the Maintenance of Wakefulness Test in Participants With Hypersomnolence
A study testing First MWT, second MWT and actimetry in people with Disorders of Excessive Somnolence, run by University Hospital, Bordeaux at 4 sites in France.
Trial summary
This study will provide the first measurement of the test-retest reliability of the Maintenance of Wakefulness Test (MWT) with a prospective multicenter design. A high level of reliability will reinforce the place of the MWT as an essential tool to respond to the medical and legal worldwide issue of the driving risk… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Disorders of Excessive Somnolence
- What is being tested?
- First MWT, second MWT and actimetry
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 4 sitesFrance
- Study dates
- 13 Nov 2025to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being affiliated or beneficiaries of a social security system.
- Having been informed of the study and having given their free and informed consent, written and signed consent to participate to the study
- Plus one of the following inclusion criteria:
- Participant with a suspicion of OSAS without any previous diagnosis or treatment and with Epworth Sleepiness Scale ≥ 11.
- Participant with effective and stable treatment for OSAS (defined by apnea-hypopnea index ≥ 15 per hour) since at least 15 days and intended to be explored by a MWT. This group will be stratified on the age (half of patients of this group < 40 years old and the other half of patients of his group ≥ 40 years old).
- Participant with effective and stable treatment for narcolepsy type 1 as defined by the ICSD-3 (cataplexy or lack of orexine) since at least 15 days and intended to be explored by a MWT.
- Healthy volunteers with Epworth Sleepiness Scale < 11.
Who cannot join
- Comorbid sleep disorders associated with excessive daytime sleepiness (e.g., OSAS and narcolepsy)
- Severe conditions endangering life in the short term
- Participant with cardiovascular, neurological, psychiatric, respiratory, infectious, endocrine, or systematic pathology, which is not stabilized and may require hospitalization or a modification of therapy during the duration of the study
- Introduction or change in dosage of a psychotropic medication in the previous year which may modify the level of arousal in the previous year and modify the MWT results
- Healthy volunteer with suspected SAOS (total score at STOP-BANG≥ 5) or suspected insomnia disorder (total score at ISI≥ 22)
- Shift or night workers
- Pregnant or breastfeeding woman
- Participants under curatorship or guardianship
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France4 sites, 4 recruiting
- Recruiting
CHU de Bordeaux
Bordeaux
Julien COELHO, Dr, 05 57 82 08 95, julien.coelho@chu-bordeaux.fr
Nathalie HEYVANG, nathalie.heyvang@chu-bordeaux.fr
- Recruiting
CHU de Montpellier
Montpellier
Lucie BARATEAU, Dr
Lucie BARATEAU, Dr
- Recruiting
APHP - Hôtel-Dieu
Paris
Alexandre ROUEN, Dr
Alexandre ROUEN
- Recruiting
APHP - la Pitié-Salpêtrière
Paris
Isabelle ARNULF, Pr
Isabelle ARNULF, Pr
About this study
This study will provide the first measurement of the test-retest reliability of the Maintenance of Wakefulness Test (MWT) with a prospective multicenter design. A high level of reliability will reinforce the place of the MWT as an essential tool to respond to the medical and legal worldwide issue of the driving risk related to hypersomnolence. This would legitimize its place as a medico-legal examination in France and promote its diffusion in other countries. A low level of reliability will call into question the place of the MWT in the management of participants with hypersomnolence. Bordeaux University Hospital is the sponsor of this research. This research will be conducted with the support of Société Française de Recherche en Médecine du Sommeil.
Read the detailed description
Hypersomnolence is a frequent and disabling symptom that has an impact on an individual's daytime functioning and particularly on driving, increasing the risk of traffic accidents related to sleepiness. Objective markers for assessing hypersomnolence are particularly important to overcome reporting bias since it is listed as a factor of temporary medical incompatibility to obtain or maintain a driving license in several countries, including France. According to the American Academy of Sleep Medicine (AASM), the MWT is the most relevant test for medico-legal assessments of fitness to drive.
Several experimental and epidemiological studies have shown that mean sleep latency at the MWT is a valid biomarker for assessing driving risk. However, there is currently no data on the test-retest reliability of the MWT from one day to the next. This is all the more important given the implications on the driving ability, and the variability associated with good participant compliance (good sleep hygiene the night before the test, absence of stimulation during the test). This study will use a factorial design to allow for stratified analyses with strong power (50 participants with Obstructive sleep apnea syndrome (OSAS), including 25 before/without treatment and 25 after/under treatment, and 25 participants with narcolepsy type 1 ,(after/under treatment) and 25 healthy volunteers. All participants will undergo an inclusion visit (V0) and two MWT (V1 and V2) separated by less than 28 days. All MWT will be twice blinded analyzed by a single expert to minimize variability of interpretation.
- Conditions
- Disorders of Excessive Somnolence
- Being tested
- First MWT, second MWT, actimetry
- Keywords
- Hypersomnolence, Driving risk, Biomarker, Maintenance of Wakefulness, Test-retest reliability
- Medical subject headings
- Disorders of Excessive Somnolence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
First MWTDiagnostic test
MWT during the first visit of the protocol
second MWTDiagnostic test
MWT during the second visit of the protocol
actimetryDevice
In order to monitor compliance with the guidelines prior to each MWT, namely good sleep hygiene in the 14 days preceding the MWT, and in accordance with the recommendations of the AASM, an actimeter will be worn by the participant.
| Study group | Role | What they receive |
|---|---|---|
| 1a | Experimental | Patient with obstructive sleep apnea (OSA) before/without treatment for OSA Receives: Diagnostic Test: First MWT; Diagnostic Test: second MWT; Device: actimetry |
| 1b | Experimental | Patient with obstructive sleep apnea (OSA) treated for OSA Receives: Diagnostic Test: First MWT; Diagnostic Test: second MWT; Device: actimetry |
| 2 | Experimental | Participants with type 1 narcolepsy Receives: Diagnostic Test: First MWT; Diagnostic Test: second MWT; Device: actimetry |
| 3 | Active comparator | Healthy volunteers Receives: Diagnostic Test: First MWT; Diagnostic Test: second MWT; Device: actimetry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean sleep latency of the MWT
Sleep latency value in the wakefulness maintenance test.
Measured: v2 (up to 90 days after V0)
Secondary outcomes (17)
Bordeaux Sleepiness Scale
Self-reported traffic accidents or near-misses related to sleepiness and sleepiness at the wheel.
4-items questionnaire. Total score of 8 points. If the score is 3 or higher, the prediction of the risk of a sleep-related accident or near miss is defined as positive.
Measured: at Baseline (day 0), v1 (up to 88 days after day 0) and v2 (up to 90 days after day 0)
Chronotype
Self-reported chronotype (reduced Morningness-Eveningness Questionnaire) It consists of 5 questions, each with a scoring system ranging from 1 to 5 points (depending on the answers), giving a total score ranging from 4 to 25.
The lower the score, the more "evening" the chronotype; the higher the score, the more "morning" the chronotype.
Measured: at Baseline (day 0), v1 (up to 88 days after day 0) and v2 (up to 90 days after day 0)
Sleepiness (1)
Self-reported sleepiness using :
- the Epworth Sleepiness Scale, 8-items, the total score ranges from 0 (normal sleepiness) to 24 (pathological sleepiness)
Measured: at Baseline (day 0), v1 (up to 88 days after day 0) and v2 (up to 90 days after day 0)
Sleepiness (2)
Self-reported sleepiness using :
- the Hypersomnia Severity Index, 9-items, the total score ranges from 0 (no hypersomnia) to 36 (Very severe Hypersomnia)
Measured: at Baseline (day 0), v1 (up to 88 days after day 0) and v2 (up to 90 days after day 0)
Sleepiness (3)
Self-reported sleepiness using :
- the Insomnia Severity Index, 7 items, the total score ranges from 0 (no insomnia) to 28 (Severe insomnia)
Measured: at Baseline (day 0), v1 (up to 88 days after day 0) and v2 (up to 90 days after day 0)
Sleepiness (4)
Self-reported sleepiness using :
- Functional Outcomes of Sleep Questionnaire, 10 items. The total score ranges from 5 ( Significant alteration) to 20 (no alteration)
Measured: at Baseline (day 0), v1 (up to 88 days after day 0) and v2 (up to 90 days after day 0)
Quality of life (1)
Self reported quality of life with :
- EQ-5D, total score from 0 (Worst possible health) to 100 ( Best possible health)
Measured: at Baseline (day 0), v1 (up to 88 days after day 0) and v2 (up to 90 days after day 0)
Quality of life (2)
Self reported quality of life with :
- Fatigue Severity Scale, 9 items, total score from 1 (Absence or low fatigue) to 7( Severe fatigue, with marked repercussions)
Measured: at Baseline (day 0), v1 (up to 88 days after day 0) and v2 (up to 90 days after day 0)
Quality of life (3)
Self reported quality of life with :
- Toronto Hospital Alertness Test, 10 items, total score from 0 (Impaired alertness (low alert)) to 50 (Good vigilance/sufficient alertness)
Measured: at Baseline (day 0), v1 (up to 88 days after day 0) and v2 (up to 90 days after day 0)
Sleep behaviors
Objective sleep behaviors (sleep duration, sleep regularity, sleep timing, using the 2-weeks actigraphy and sleep diary).
Measured: at Baseline (day 0), v1 (up to 88 days after day 0) and v2 (up to 90 days after day 0)
Appropriate disorder (1)
Self-reported severity scale for appropriate disorder using :
- The Patient Reported Apnea Questionnaire, 16 items (from 0 to 5), The higher the score, the greater the negative impact of Obstructive Sleep Apnea.
- The Narcolepsy Severity Scale, 15 items, the higher the score, the more severe the symptoms.
Measured: at Baseline (day 0), v1 (up to 88 days after day 0) and v2 (up to 90 days after day 0)
Appropriate disorder (2)
Self-reported severity scale for appropriate disorder using :
- The Narcolepsy Severity Scale, 15 items, the higher the score, the more severe the symptoms.
Measured: at Baseline (day 0), v1 (up to 88 days after day 0) and v2 (up to 90 days after day 0)
Mental complaints (1)
Mental complaints using :
- The Generalized Anxiety Disorder-7, 7 items, total score from 0 (no anxiety) to 21(severe anxiety)
Measured: at Baseline (day 0), v1 (up to 88 days after day 0) and v2 (up to 90 days after day 0)
Mental complaints (2)
Mental complaints using :
- The Perceived Stress Scale, 10 items, total score from 0 (Low stress) to 40 (High stress)
Measured: at Baseline (day 0), v1 (up to 88 days after day 0) and v2 (up to 90 days after day 0)
Mental complaints (3)
Mental complaints using :
- The Psychological-Physical-Pain Visual Analogue Scale, 3 items from 0 (no pain) to 100 (maximal pain)
Measured: at Baseline (day 0), v1 (up to 88 days after day 0) and v2 (up to 90 days after day 0)
Mental complaints (4)
Mental complaints using :
- The Adult Self-Report Scale, 18 items, total score from 0(no symptom) to 72 (very frequent/severe symptoms)
Measured: at Baseline (day 0), v1 (up to 88 days after day 0) and v2 (up to 90 days after day 0)
Mental complaints (5)
Mental complaints using :
- The Participant Health Questionnaire-9, 9 items, total score from 0(no depression) to 27 (severe depression)
Measured: at Baseline (day 0), v1 (up to 88 days after day 0) and v2 (up to 90 days after day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start13 Nov 2025
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disorders of Excessive SomnolenceStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- Société Française de Recherche et Médecine du Sommeil (S.F.R.M.S)
- Responsible party
- Sponsor
- Investigators
- Jean-Arthur MICOULAUD-FRANCHI, Pr, Principal investigator, University Hospital, BordeauxJulien COELHO, Dr, Study chair, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07120061
- Sponsor's protocol ID
- CHUBX 2024/88
- Acronym
- REWIND
- Status last verified
- Mar 2026
- First submitted
- 29 Jul 2025
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Test-retest Reliability of the Maintenance of Wakefulness Test in Participants With Hypersomnolence
- ClinicalTrials.gov ID
- NCT07120061
- Acronym / sponsor ID
- REWIND / CHUBX 2024/88
- Conditions
- Disorders of Excessive Somnolence
- Keywords
- Hypersomnolence, Driving risk, Biomarker, Maintenance of Wakefulness, Test-retest reliability
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- Société Française de Recherche et Médecine du Sommeil (S.F.R.M.S)
- Study start
- 13 Nov 2025 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 13 Aug 2025 (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.
This study will provide the first measurement of the test-retest reliability of the Maintenance of Wakefulness Test (MWT) with a prospective multicenter design. A high level of reliability will reinforce the place of the MWT as an essential tool to respond to the medical and legal worldwide issue of the driving risk related to hypersomnolence. This would legitimize its place as a medico-legal examination in France and promote its diffusion in other countries. A low level of reliability will call into question the place of the MWT in the management of participants with hypersomnolence. Bordeaux University Hospital is the sponsor of this research. This research will be conducted with the support of Société Française de Recherche en Médecine du Sommeil.
Detailed description
Hypersomnolence is a frequent and disabling symptom that has an impact on an individual's daytime functioning and particularly on driving, increasing the risk of traffic accidents related to sleepiness. Objective markers for assessing hypersomnolence are particularly important to overcome reporting bias since it is listed as a factor of temporary medical incompatibility to obtain or maintain a driving license in several countries, including France. According to the American Academy of Sleep Medicine (AASM), the MWT is the most relevant test for medico-legal assessments of fitness to drive.
Several experimental and epidemiological studies have shown that mean sleep latency at the MWT is a valid biomarker for assessing driving risk. However, there is currently no data on the test-retest reliability of the MWT from one day to the next. This is all the more important given the implications on the driving ability, and the variability associated with good participant compliance (good sleep hygiene the night before the test, absence of stimulation during the test). This study will use a factorial design to allow for stratified analyses with strong power (50 participants with Obstructive sleep apnea syndrome (OSAS), including 25 before/without treatment and 25 after/under treatment, and 25 participants with narcolepsy type 1 ,(after/under treatment) and 25 healthy volunteers. All participants will undergo an inclusion visit (V0) and two MWT (V1 and V2) separated by less than 28 days. All MWT will be twice blinded analyzed by a single expert to minimize variability of interpretation.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1a | Experimental | Diagnostic Test: First MWT, Diagnostic Test: second MWT, Device: actimetryPatient with obstructive sleep apnea (OSA) before/without treatment for OSA |
| 1b | Experimental | Diagnostic Test: First MWT, Diagnostic Test: second MWT, Device: actimetryPatient with obstructive sleep apnea (OSA) treated for OSA |
| 2 | Experimental | Diagnostic Test: First MWT, Diagnostic Test: second MWT, Device: actimetryParticipants with type 1 narcolepsy |
| 3 | Active comparator | Diagnostic Test: First MWT, Diagnostic Test: second MWT, Device: actimetryHealthy volunteers |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Being affiliated or beneficiaries of a social security system.
- Having been informed of the study and having given their free and informed consent, written and signed consent to participate to the study
- Participant with a suspicion of OSAS without any previous diagnosis or treatment and with Epworth Sleepiness Scale ≥ 11.
- Participant with effective and stable treatment for OSAS (defined by apnea-hypopnea index ≥ 15 per hour) since at least 15 days and intended to be explored by a MWT. This group will be stratified on the age (half of patients of this group < 40 years old and the other half of patients of his group ≥ 40 years old).
- Participant with effective and stable treatment for narcolepsy type 1 as defined by the ICSD-3 (cataplexy or lack of orexine) since at least 15 days and intended to be explored by a MWT.
Key exclusion criteria (8 listed)
- Comorbid sleep disorders associated with excessive daytime sleepiness (e.g., OSAS and narcolepsy)
- Severe conditions endangering life in the short term
- Participant with cardiovascular, neurological, psychiatric, respiratory, infectious, endocrine, or systematic pathology, which is not stabilized and may require hospitalization or a modification of therapy during the duration of the study
- Introduction or change in dosage of a psychotropic medication in the previous year which may modify the level of arousal in the previous year and modify the MWT results
- Healthy volunteer with suspected SAOS (total score at STOP-BANG≥ 5) or suspected insomnia disorder (total score at ISI≥ 22)
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 |
|---|---|---|
| First MWTMWT during the first visit of the protocol | Diagnostic test | 1a, 1b, 2, 3 |
| second MWTMWT during the second visit of the protocol | Diagnostic test | 1a, 1b, 2, 3 |
| actimetryIn order to monitor compliance with the guidelines prior to each MWT, namely good sleep hygiene in the 14 days preceding the MWT, and in accordance with the recommendations of the AASM, an actimeter will be worn by the participant. | Device | 1a, 1b, 2, 3 |
Primary outcome
Mean sleep latency of the MWT
Time frame: v2 (up to 90 days after V0)
Sleep latency value in the wakefulness maintenance test.
17 secondary outcomes
Bordeaux Sleepiness Scale
Time frame: at Baseline (day 0), v1 (up to 88 days after day 0) and v2 (up to 90 days after day 0)
Chronotype
Time frame: at Baseline (day 0), v1 (up to 88 days after day 0) and v2 (up to 90 days after day 0)
Sleepiness (1)
Time frame: at Baseline (day 0), v1 (up to 88 days after day 0) and v2 (up to 90 days after day 0)
Sleepiness (2)
Time frame: at Baseline (day 0), v1 (up to 88 days after day 0) and v2 (up to 90 days after day 0)
Sleepiness (3)
Time frame: at Baseline (day 0), v1 (up to 88 days after day 0) and v2 (up to 90 days after day 0)
Sleepiness (4)
Time frame: at Baseline (day 0), v1 (up to 88 days after day 0) and v2 (up to 90 days after day 0)
Quality of life (1)
Time frame: at Baseline (day 0), v1 (up to 88 days after day 0) and v2 (up to 90 days after day 0)
Quality of life (2)
Time frame: at Baseline (day 0), v1 (up to 88 days after day 0) and v2 (up to 90 days after day 0)
Quality of life (3)
Time frame: at Baseline (day 0), v1 (up to 88 days after day 0) and v2 (up to 90 days after day 0)
Sleep behaviors
Time frame: at Baseline (day 0), v1 (up to 88 days after day 0) and v2 (up to 90 days after day 0)
Appropriate disorder (1)
Time frame: at Baseline (day 0), v1 (up to 88 days after day 0) and v2 (up to 90 days after day 0)
Appropriate disorder (2)
Time frame: at Baseline (day 0), v1 (up to 88 days after day 0) and v2 (up to 90 days after day 0)
Mental complaints (1)
Time frame: at Baseline (day 0), v1 (up to 88 days after day 0) and v2 (up to 90 days after day 0)
Mental complaints (2)
Time frame: at Baseline (day 0), v1 (up to 88 days after day 0) and v2 (up to 90 days after day 0)
Mental complaints (3)
Time frame: at Baseline (day 0), v1 (up to 88 days after day 0) and v2 (up to 90 days after day 0)
Mental complaints (4)
Time frame: at Baseline (day 0), v1 (up to 88 days after day 0) and v2 (up to 90 days after day 0)
Mental complaints (5)
Time frame: at Baseline (day 0), v1 (up to 88 days after day 0) and v2 (up to 90 days after day 0)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Disorders of Excessive Somnolence
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
RecruitingPhase 2/3
A Study of TAK-360 in People With Narcolepsy or Idiopathic Hypersomnia
Idiopathic Hypersomnia, Narcolepsy Type 1
RecruitingPhase 2/3
A Study to Investigate the Effects of Cleminorexton Compared With Placebo in the Treatment of Participants With Central Disorders of Hypersomnolence
Narcolepsy Type 1, Narcolepsy Type 2
Active, not recruitingPhase 3
A Trial of TAK-861 for the Treatment of Narcolepsy With Cataplexy
Narcolepsy Type 1 (NT1), Narcolepsy With Cataplexy
RecruitingPhase 2
A Study to Evaluate the Safety and Efficacy of ALKS 7290 as an Adjunctive Therapy to Antidepressants in Adult Participants With Major Depressive Disorder
Major Depressive Disorder (MDD)
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.
Jean-Arthur MICOULAUD-FRANCHI, Pr principal investigator
University Hospital, Bordeaux
Julien COELHO, Dr study chair
University Hospital, Bordeaux
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing First MWT, second MWT and actimetry in people with Disorders of Excessive Somnolence, run by University Hospital, Bordeaux 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 8 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: looking for participants now, as of the sponsor's last update on 17 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julien COELHO, Dr (05 57 82 08 95, julien.coelho@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean sleep latency of the MWT (time frame: v2 (up to 90 days after V0)). 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 17 Mar 2026.