TerminatedNot Applicable

Cardiovascular Impairments and Obstructive Sleep Apnea Syndrome

Stopped: Delayed inclusion at more than 14 years from the start of the study

France133 participantsStarted 2007-11

Plain-language summary

Which are the anthropometric parameters and/or of severity of the syndrome of apnea of sleep (SAS) which make it possible to anticipate occurred of vascular anomalies, anatomical and/or functional precociously found among patients SAS? Secondary objectives: 1. Which are the anthropometric parameters and/or of severity of SAS allowing to anticipate occurred of early of the cardiac function and/or rhythmic anomalies found among patients SAS? 2. Do there exist biological markers who allow to anticipate the early vascular lesions or the anomalies beginners of the cardiac function? 3. Which are the cardiovascular effects of a treatment of SAS by Continuous Positive Pressure (PC) after 3 to 6 months of treatment? 4. Do the identified early cardiovascular attacks and/or the biological anomalies make it possible to predict occurred of cardiovascular events in this population of patients carrying SAS (followed longitudinal at 5 years)?

Who can participate

Age range

18 Years – 78 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: * Male or female from 18 to 78 years old * Patients with obstructive sleep apnea syndrome (Apnea/Hypopnea index \> 15) * ambulatory patients * patients who have signed the inform consent form * patients with health insurance Exclusion Criteria: * Body Mass Index upper or equal to 30 * cardiovascular pathology except blood pressure hypertension * known or treated diabetes * pathologies with consequence on blood pressure regulation * drugs intakes with consequence on blood pressure regulation * patient with chronic obstructive pulmonary disease * atrial fibrillation or more than 10/minute extrasystoles * bedridden patients or patients with decreased mobility * patients working at night or with shift work * patients with carotid stenting or surgery history * patients unable to sign the inform consent form * patients already treated by cPAP or dental appliance for OSAS in the last 6 months * pregnant or suckling female * patients under supervision or trusteeship * patients taking part in another clinical trial

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.

Trial details

NCT IDNCT01089257

SponsorUniversity Hospital, Grenoble

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2012-11

View on ClinicalTrials.gov More Subclinical Cardiovascular Impairments trials