Effect of Exercise Training on Obstructive Sleep Apnea Syndrome Severity (NCT02463890) | Clinical Trial Compass
CompletedNot Applicable
Effect of Exercise Training on Obstructive Sleep Apnea Syndrome Severity
France96 participantsStarted 2015-06-08
Plain-language summary
Sleep apnoea affects more than 20% of people over 65 years and is largely underdiagnosed. It does multiply tenfold the occurrence of vascular events, particularly stroke. While Continuous Positive Airway Pressure (CPAP) is currently the Gold standard treatment to prevent cerebrovascular and cardiovascular events, with a major clinical benefit, long term adherence to CPAP is a significant problem and search for alternative treatment is essential.
The investigators hypothesize that long-term exercise training would allow to reduce significantly sleep apnoea syndrome severity. Thus, in this study, the investigators will compare evolution of Apnoea Hypopnea Index (AHI) in an exercise trained group performed through in a national based non-profit organization (Fédération Française d'éducation Physique et de Gymnastique Volontaire (FFEPGV)) using a medical established program (NeuroGyV) during nine months against a control group receiving only standard dietetic and physical activity counseling.
Who can participate
Age range
40 Years – 80 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:
* Patients affiliated or entitled to a social security system
* Patients with AHI from 15 to 30 per hour
* Signature of consent
Exclusion Criteria:
* Patients being already treated for sleep apnea or clinical status (cardiovascular comorbidities) justifying an immediate initiation of CPAP
* Daytime sleepiness (ESS score \> 10)
* Known respiratory or heart disease (or discovering during stress test) contraindicated exercise training
* Patients with Parkinson's disease
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.
1This trial looked at exercise training as a way to affect obstructive sleep apnea severity, measured by a final sleep study — based on what this trial found, could an exercise program realistically help reduce the severity of my sleep apnea, and would that be worth trying alongside or instead of CPAP?
2Since this trial is completed, has my doctor seen the published results, and what do those results actually show about how much exercise training changed participants' sleep apnea scores on the polysomnography?
3This study was listed as 'Phase NA,' meaning it wasn't testing a drug but rather a lifestyle intervention — does that change how confident my doctor feels about the safety and reliability of exercise as a treatment approach for my specific situation?
4What type or intensity of exercise program was likely used in this trial, and is that something that would realistically fit into my daily life given my current health and fitness level?
5Would my doctor recommend I consider an exercise-based approach based on trials like this one, or is there a standard treatment like CPAP or a weight-loss program that evidence more strongly supports as a first step for someone with my level of sleep apnea?
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
Final polysomnography
Timeframe: 9 months
Trial details
NCT IDNCT02463890
SponsorCentre Hospitalier Universitaire de Saint Etienne