Follow-up of the Patients Included in the EXESAS Study (NCT02920723) | Clinical Trial Compass
CompletedNot Applicable
Follow-up of the Patients Included in the EXESAS Study
France79 participantsStarted 2016-09-01
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.
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:
* Included in the previous EXESAS study
* 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
* AHI \> 30
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
the AHI (number of Apnea+Hypopnea per hour) through polysomnography assessment after twelve months of follow-up in the training and the control groups
Timeframe: 12 months
Trial details
NCT IDNCT02920723
SponsorCentre Hospitalier Universitaire de Saint Etienne