m-Rehab OSA : Impact of a Telerehabilitation Program Associated With CPAP on Severity Markers of … (NCT05049928) | Clinical Trial Compass
CompletedNot Applicable
m-Rehab OSA : Impact of a Telerehabilitation Program Associated With CPAP on Severity Markers of Obstructive Sleep Apnea Syndrome
France180 participantsStarted 2021-09-27
Plain-language 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. 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.
Who can participate
Age range
30 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Severe obstructive sleep apnea (apnea-hypopnea index ≥30 / hour)
* Body mass index ≥ 30 kg / m²
* age between 30 and 75 years old
* written consent
Exclusion Criteria:
* 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
* 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 dep…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from baseline daytime sleepness at 6 months
Timeframe: Between baseline and 6 month visit
2
Change from baseline quality of life at 6 months
Timeframe: Between baseline and 6 month visit
3
Change from baseline systolic blood pressure at 6 months