Obstructive Sleep Apnea SyndromemRehabOSANCT05049928
m-Rehab OSA : Impact of a Telerehabilitation Program Associated With CPAP on Severity Markers of Obstructive Sleep Apnea Syndrome
A study testing Telerehabilitation solution (m-Rehab) in people with Obstructive Sleep Apnea Syndrome, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Obstructive sleep apnea syndrome (OSA) is a common condition associated with major repercussions such as excessive daytime sleepiness and impaired quality of life as well as metabolic and cardiovascular complications. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Obstructive Sleep Apnea Syndrome
- What is being tested?
- Telerehabilitation solution (m-Rehab)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteFrance
- Study dates
- 27 Sep 2021to 5 Jun 2024
- 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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Severe obstructive sleep apnea (apnea-hypopnea index ≥30 / hour)
- Body mass index ≥ 30 kg / m²
- age between 30 and 75 years old
- written consent
Who cannot join
- Presence of contraindications to perform exercise training (neuromuscular disease, orthopedic cause, acute coronary syndrome or stroke in the previous three months)
- Active infection, chronic inflammatory disease, cancer under treatment. Systemic treatment with immunosuppressants or corticosteroids
- Obstructive Sleep Apnea treated by Continuous Positive Airway Pressure or mandibular advancement device in the 3 months preceding inclusion
- Participation in a rehabilitation program scheduled within six months of inclusion
- Predominantly central sleep apnea syndrome (AC> 50%)
- Heart failure with Left Ventricular Ejection Fraction <40% known
Show all 15Show fewer
- Bariatric surgery in the previous 6 months or bariatric surgery project in the 6 months
- Alcohol> 14 drinks per week
- Inability to understand and / or answer questionnaires.
- Refusal to use a smartphone or digital device
- Inability to access an internet connection at home.
- Subject in a period of relative exclusion with respect to another protocol or for which the maximum annual amount of compensation of € 4,500 has been reached.
- Subject not affiliated with a social security scheme, or not beneficiary of such a scheme.
- Pregnant or breastfeeding woman, patient unable to give her protected adult consent, vulnerable people
- Subject deprived of liberty by judicial or administrative decision
Trial locations and contacts
1 site in 1 country.
About this study
Official title: m-Rehab OSA : Impact of a Telerehabilitation Program Associated With CPAP on Severity Markers of Obstructive Sleep Apnea Syndrome. Prospective, Randomized, Controlled, Multicenter Study
Obstructive sleep apnea syndrome (OSA) is a common condition associated with major repercussions such as excessive daytime sleepiness and impaired quality of life as well as metabolic and cardiovascular complications. Continuous positive airway pressure (CPAP) remains the treatment of choice but its effectiveness remains limited, especially in reducing cardio-metabolic risk. Interventions to modify the lifestyle are therefore recommended in the management of OSA. The emergence of information and communication technologies is an opportunity for patients to have tools that promote self-management and behavioral changes. The recent development of telerehabilitation (TR) is a promising approach that has only been the subject of pilot studies. In a randomized, controlled and multicenter study, we propose to test the hypothesis according to which the use of a mobile TR solution, associated with continuous positive airway pressure (CPAP), will allow obese patients to adopt behavioral modifications to improve markers of severity of OSA. The analysis of big data (data-mining) will allow a better understanding of the motivational obstacles and levers.
Read the detailed description
Statistical analysis plan The number of patients solicited for the study and the number of subjects included and randomized in each group will be reported on the flow chart. Premature stops (lost to follow-up, death, study withdrawals) and their reasons will be reported as well as any deviations from the protocol.
An initial descriptive analysis of each of the groups will be carried out. For qualitative variables, this description will include the number as well as the frequency of the different modalities. Concerning the quantitative variables, the description will include the number, the mean, the standard deviation, the median as well as the extreme values according to the distribution.
The comparability of the 2 groups will be verified for all the initial characteristics likely to influence the results. In the event of non-comparability on one or more parameters, an adjustment will be made on this or these parameters for the comparisons between groups of judgment criteria.
Analysis of the primary judgment criterion The variation in the evolution of the various main criteria will be compared between the 2 groups using a nonparametric means comparison test (Mann-Whitney test) or if the distribution turns out to be Gaussian and the conditions application are verified, a parametric test (Student's T).
Analysis of secondary endpoints The qualitative variables will be compared by a Chi-square test. Otherwise, if the conditions for performing this test are not met, Fisher's exact test will be used.
The quantitative variables will be compared between the two groups:
- in the case of Gaussian variables, by a student's t test or an analysis of variance
- in the case of non-Gaussian variables, by a Wilcoxon-Mann-Withney test
Longitudinal data (quality of life scores, physical activities) will be modeled by a mixed regression with the patient effect as a random variable. A linear regression model modeling the variation of the longitudinal endpoints will be fitted to the covariates having at least one trend (p <0.15) to the difference between the two arms of the study. A forward type procedure will be implemented to obtain a final multivariate model.
Management of missing data:
The IPTW method will be used. The lost to follow-up will be considered using a weighting on the inverse of the probability of being censored
- Conditions
- Obstructive Sleep Apnea Syndrome
- Being tested
- Telerehabilitation solution (m-Rehab)
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telerehabilitation solution (m-Rehab)Other
The telerehabilitation program consists of the following elements:
- Mobile applications and website usable on smartphone and tablet for the patient.
- Teleconsultation solution for the patient and the doctors.
- Video conferencing solution for professionals involved in patient follow-up: educators in adapted physical activity, physiotherapists, psychologists, dieticians, etc.
- Web interface for health professionals allowing the collection and monitoring of various parameters in physical activity and nutrition as well as progress in therapeutic education activities.
- Withings® connected objects
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Experimental | Patients in the experimental group will be treated with CPAP (PRISMA, LOWENSTEIN®) and will have access to the m-Rehab® telerehabilitation program. Receives: Other: Telerehabilitation solution (m-Rehab) |
| Control arm | No intervention | Patients in the experimental group will be treated with CPAP (PRISMA, LOWENSTEIN) and will receive the usual advice on adapted physical activity and nutrition during the initial consultation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline daytime sleepness at 6 months
Epworth questionnaire
Measured: Between baseline and 6 month visit
Change from baseline quality of life at 6 months
Functional Outcomes of Sleep Questionnaire (FOSQ)
Measured: Between baseline and 6 month visit
Change from baseline systolic blood pressure at 6 months
Blood pressure : nocturnal systolic BP (ambulatory blood pressure measurement)
Measured: Between baseline and 6 month visit
Change from baseline inflammation at 6 months
C-reactive protein in blood
Measured: Between baseline and 6 month visit
Secondary outcomes (28)
Evolution of fatigue in experimental and control group
Pichot questionnaire
Measured: Between inclusion and 6 month visit
Evolution of quality of life in experimental and control group
EQ5D (EuroQol) questionnaire
Measured: Between inclusion and 6 month visit
Evolution of sleep quality in experimental and control group
Pittsburg questionnaire
Measured: Between inclusion and 6 month visit
Evolution of anxiety and depression in experimental and control group with Hospital Anxiety and Depression scale
Anxiety and depression will be evaluated with the HAD (Hospital Anxiety and Depression) scale (values 0-21 with higher score meaning a worse outcome).
Measured: Between inclusion and 6 month visit
Evolution of sleepiness in experimental and control group (Epworth)
Percentage of patients with Epworth fall> 2
Measured: Between inclusion and 6 month visit
Evolution of sleepiness in experimental and control group (IHSS)
Assessed by the Idiopathic Hypersomnia Severity Scale. The total score is 0 to 50 with a higher score indicating more drowsiness.
Measured: Between inclusion and 6 month visit
Evolution of sleepiness in experimental and control group (iterative sleep latency tests)
Evaluated by iterative sleep latency tests
Measured: Between inclusion and 6 month visit
Evolution of the architecture of sleep in experimental and control group
Architecture of sleep will be evaluated with polysomnography : Stages of sleep (Stages N1 N2, N3 and REM in minutes and %), sleep efficiency (%), micro-arousal index (number of events/hour)
Measured: Between inclusion and 6 month visit
Evolution of polysomnographic markers in experimental and control group
time spent under a SpO2 of 90%
Measured: Between inclusion and 6 month visit
Evolution of physical activity parameters in experimental and control group (IPAQ)
evaluated by International Physical Activity Questionnaire (IPAQ)
Measured: Between inclusion and 6 month visit
Evolution of physical activity parameters in experimental and control group (actimetry)
evaluated by actimetry (number of steps)
Measured: Between inclusion and 6 month visit
Evolution of nutritional parameters in experimental and control group
assessed by dietary calendar
Measured: Between inclusion and 6 month visit
Evolution of exercise tolerance in experimental and control group
assessed by exercise test on a cycloergometer
Measured: Between inclusion and 6 month visit
Evolution of anthropometric parameters in experimental and control group
ratio of waist circumference to hip circumference
Measured: Between inclusion and 6 month visit
Evolution of biological parameters in experimental and control group (fasting blood sugar)
Measured: Between inclusion and 6 month visit
Evolution of biological parameters in experimental and control group (total cholesterol)
Measured: Between inclusion and 6 month visit
Evolution of biological parameters in experimental and control group (LDL cholesterol)
Measured: Between inclusion and 6 month visit
Evolution of biological parameters in experimental and control group (HDL cholesterol)
Measured: Between inclusion and 6 month visit
Evolution of biological parameters in experimental and control group (triglycerides)
Measured: Between inclusion and 6 month visit
Evolution of biological parameters in experimental and control group (glycated haemoglobin (HbA1c))
Measured: Between inclusion and 6 month visit
Evolution of endothelial function in experimental and control group
assessed by endoPAT
Measured: Between inclusion and 6 month visit
Evolution of blood pressure profile parameters in experimental and control group
evaluated by ambulatory blood pressure measurement over 24 hours
Measured: Between inclusion and 6 month visit
Evolution of adherence to Continuous positive airway pressure (CPAP) in experimental and control group
Measured: Between inclusion and 6 month visit
Evolution of adherence to Continuous positive airway pressure (CPAP) in experimental and control group
Measured: Between inclusion and 3 month visit
Evolution of adherence to Continuous positive airway pressure (CPAP) in experimental and control group
Measured: Between inclusion and 1 month visit
Assessment of individual factors influencing CPAP adherence in experimental and control group
The individual factors studied are gender, body mass index and age.
Measured: Between inclusion and 6 month visit
Assessment of device-related factors influencing CPAP adherence in experimental and control group
The device-related factors are are the type of mask, fixed or autopilot mode and whether or not a humidifier is used. The factors of the CPAP are: residual IAH (number/hour), the pressure P90 (cmH2O), the leaks (% and liter/minute), the duration of deep sleep (minutes and %) evaluated by the CPAP.
Measured: Between inclusion and 6 month visit
Assessment of the incremental cost-utility ratio in experimental and control group
Measured: At 6 month visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2021
- Study start27 Sep 2021
- Primary completion5 Jan 2024
- Study completion5 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep Apnea SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05049928
- Sponsor's protocol ID
- RECHMPL19_0062
- Other IDs
- 2020-A02100-39
- Acronym
- mRehabOSA
- Status last verified
- Sep 2023
- First submitted
- 20 Aug 2021
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bughin F, Mendelson M, Jaffuel D, Pepin JL, Gagnadoux F, Goutorbe F, Abril B, Ayoub B, Aranda A, Alagha K, Pomies P, Roubille F, Mercier J, Molinari N, Dauvilliers Y, Heraud N, Hayot M. Impact of a telerehabilitation programme combined with continuous positive airway pressure on symptoms and cardiometabolic risk factors in obstructive sleep apnea patients. Digit Health. 2023 Apr 6;9:20552076231167009. doi: 10.1177/20552076231167009. eCollection 2023 Jan-Dec.
PubMed 37051564
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- m-Rehab OSA : Impact of a Telerehabilitation Program Associated With CPAP on Severity Markers of Obstructive Sleep Apnea Syndrome. Prospective, Randomized, Controlled, Multicenter Study
- ClinicalTrials.gov ID
- NCT05049928
- Acronym / sponsor ID
- mRehabOSA / RECHMPL19_0062
- Conditions
- Obstructive Sleep Apnea Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 27 Sep 2021 (actual)
- Primary completion
- 5 Jan 2024 (actual)
- Study completion
- 5 Jun 2024 (actual)
- First posted
- 20 Sep 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.
Obstructive sleep apnea syndrome (OSA) is a common condition associated with major repercussions such as excessive daytime sleepiness and impaired quality of life as well as metabolic and cardiovascular complications. Continuous positive airway pressure (CPAP) remains the treatment of choice but its effectiveness remains limited, especially in reducing cardio-metabolic risk. Interventions to modify the lifestyle are therefore recommended in the management of OSA. The emergence of information and communication technologies is an opportunity for patients to have tools that promote self-management and behavioral changes. The recent development of telerehabilitation (TR) is a promising approach that has only been the subject of pilot studies. In a randomized, controlled and multicenter study, we propose to test the hypothesis according to which the use of a mobile TR solution, associated with continuous positive airway pressure (CPAP), will allow obese patients to adopt behavioral modifications to improve markers of severity of OSA. The analysis of big data (data-mining) will allow a better understanding of the motivational obstacles and levers.
Detailed description
Statistical analysis plan The number of patients solicited for the study and the number of subjects included and randomized in each group will be reported on the flow chart. Premature stops (lost to follow-up, death, study withdrawals) and their reasons will be reported as well as any deviations from the protocol.
An initial descriptive analysis of each of the groups will be carried out. For qualitative variables, this description will include the number as well as the frequency of the different modalities. Concerning the quantitative variables, the description will include the number, the mean, the standard deviation, the median as well as the extreme values according to the distribution.
The comparability of the 2 groups will be verified for all the initial characteristics likely to influence the results. In the event of non-comparability on one or more parameters, an adjustment will be made on this or these parameters for the comparisons between groups of judgment criteria.
Analysis of the primary judgment criterion The variation in the evolution of the various main criteria will be compared between the 2 groups using a nonparametric means comparison test (Mann-Whitney test) or if the distribution turns out to be Gaussian and the conditions application are verified, a parametric test (Student's T).
Analysis of secondary endpoints The qualitative variables will be compared by a Chi-square test. Otherwise, if the conditions for performing this test are not met, Fisher's exact test will be used.
The quantitative variables will be compared between the two groups:
- in the case of Gaussian variables, by a student's t test or an analysis of variance
- in the case of non-Gaussian variables, by a Wilcoxon-Mann-Withney test
Longitudinal data (quality of life scores, physical activities) will be modeled by a mixed regression with the patient effect as a random variable. A linear regression model modeling the variation of the longitudinal endpoints will be fitted to the covariates having at least one trend (p <0.15) to the difference between the two arms of the study. A forward type procedure will be implemented to obtain a final multivariate model.
Management of missing data:
The IPTW method will be used. The lost to follow-up will be considered using a weighting on the inverse of the probability of being censored
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Other: Telerehabilitation solution (m-Rehab)Patients in the experimental group will be treated with CPAP (PRISMA, LOWENSTEIN®) and will have access to the m-Rehab® telerehabilitation program. |
| Control arm | No intervention | –Patients in the experimental group will be treated with CPAP (PRISMA, LOWENSTEIN) and will receive the usual advice on adapted physical activity and nutrition during the initial consultation. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Severe obstructive sleep apnea (apnea-hypopnea index ≥30 / hour)
- Body mass index ≥ 30 kg / m²
- age between 30 and 75 years old
- written consent
Key exclusion criteria (15 listed)
- Presence of contraindications to perform exercise training (neuromuscular disease, orthopedic cause, acute coronary syndrome or stroke in the previous three months)
- Active infection, chronic inflammatory disease, cancer under treatment. Systemic treatment with immunosuppressants or corticosteroids
- Obstructive Sleep Apnea treated by Continuous Positive Airway Pressure or mandibular advancement device in the 3 months preceding inclusion
- Participation in a rehabilitation program scheduled within six months of inclusion
- Predominantly central sleep apnea syndrome (AC> 50%)
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 |
|---|---|---|
| Telerehabilitation solution (m-Rehab)The telerehabilitation program consists of the following elements: * Mobile applications and website usable on smartphone and tablet for the patient. * Teleconsultation solution for the patient and the doctors. * Video conferencing solution for professionals involved in patient follow-up: educators in adapted physical activity, physiotherapists, psychologists, dieticians, etc. * Web interface for health professionals allowing the collection and monitoring of various parameters in physical activity and nutrition as well as progress in therapeutic education activities. * Withings® connected objects | Other | Experimental arm |
Primary outcome
Change from baseline daytime sleepness at 6 months
Time frame: Between baseline and 6 month visit
Epworth questionnaire
Change from baseline quality of life at 6 months
Time frame: Between baseline and 6 month visit
Functional Outcomes of Sleep Questionnaire (FOSQ)
Change from baseline systolic blood pressure at 6 months
Time frame: Between baseline and 6 month visit
Blood pressure : nocturnal systolic BP (ambulatory blood pressure measurement)
Change from baseline inflammation at 6 months
Time frame: Between baseline and 6 month visit
C-reactive protein in blood
28 secondary outcomes
Evolution of fatigue in experimental and control group
Time frame: Between inclusion and 6 month visit
Evolution of quality of life in experimental and control group
Time frame: Between inclusion and 6 month visit
Evolution of sleep quality in experimental and control group
Time frame: Between inclusion and 6 month visit
Evolution of anxiety and depression in experimental and control group with Hospital Anxiety and Depression scale
Time frame: Between inclusion and 6 month visit
Evolution of sleepiness in experimental and control group (Epworth)
Time frame: Between inclusion and 6 month visit
Evolution of sleepiness in experimental and control group (IHSS)
Time frame: Between inclusion and 6 month visit
Evolution of sleepiness in experimental and control group (iterative sleep latency tests)
Time frame: Between inclusion and 6 month visit
Evolution of the architecture of sleep in experimental and control group
Time frame: Between inclusion and 6 month visit
Evolution of polysomnographic markers in experimental and control group
Time frame: Between inclusion and 6 month visit
Evolution of physical activity parameters in experimental and control group (IPAQ)
Time frame: Between inclusion and 6 month visit
Evolution of physical activity parameters in experimental and control group (actimetry)
Time frame: Between inclusion and 6 month visit
Evolution of nutritional parameters in experimental and control group
Time frame: Between inclusion and 6 month visit
Evolution of exercise tolerance in experimental and control group
Time frame: Between inclusion and 6 month visit
Evolution of anthropometric parameters in experimental and control group
Time frame: Between inclusion and 6 month visit
Evolution of biological parameters in experimental and control group (fasting blood sugar)
Time frame: Between inclusion and 6 month visit
Evolution of biological parameters in experimental and control group (total cholesterol)
Time frame: Between inclusion and 6 month visit
Evolution of biological parameters in experimental and control group (LDL cholesterol)
Time frame: Between inclusion and 6 month visit
Evolution of biological parameters in experimental and control group (HDL cholesterol)
Time frame: Between inclusion and 6 month visit
Evolution of biological parameters in experimental and control group (triglycerides)
Time frame: Between inclusion and 6 month visit
Evolution of biological parameters in experimental and control group (glycated haemoglobin (HbA1c))
Time frame: Between inclusion and 6 month visit
Evolution of endothelial function in experimental and control group
Time frame: Between inclusion and 6 month visit
Evolution of blood pressure profile parameters in experimental and control group
Time frame: Between inclusion and 6 month visit
Evolution of adherence to Continuous positive airway pressure (CPAP) in experimental and control group
Time frame: Between inclusion and 6 month visit
Evolution of adherence to Continuous positive airway pressure (CPAP) in experimental and control group
Time frame: Between inclusion and 3 month visit
Evolution of adherence to Continuous positive airway pressure (CPAP) in experimental and control group
Time frame: Between inclusion and 1 month visit
Assessment of individual factors influencing CPAP adherence in experimental and control group
Time frame: Between inclusion and 6 month visit
Assessment of device-related factors influencing CPAP adherence in experimental and control group
Time frame: Between inclusion and 6 month visit
Assessment of the incremental cost-utility ratio in experimental and control group
Time frame: At 6 month visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Results publication: PubMed 37051564Bughin F, Mendelson M, Jaffuel D, Pepin JL, Gagnadoux F, Goutorbe F, Abril B, Ayoub B, Aranda A, Alagha K, Pomies P, Roubille F, Mercier J, Molinari N, Dauvilliers Y, Heraud N, Hayot M. Impact of a telerehabilitation programme combined with continuous positive airway pressure on symptoms and cardiometabolic risk factors in obstructive sleep apnea patients. Digit Health. 2023 Apr 6;9:20552076231167009. doi: 10.1177/20552076231167009. eCollection 2023 Jan-Dec.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telerehabilitation solution (m-Rehab) in people with Obstructive Sleep Apnea Syndrome, run by University Hospital, Montpellier at 1 site 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 4 inclusion and 15 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: finished, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from baseline daytime sleepness at 6 months (time frame: Between baseline and 6 month visit). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05049928, which also lists 1 linked publication.
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 12 Jun 2026.