CompletedNot Applicable

Evolution of Oxidative Stress in Coronary Patients With Moderate Sleep Apnea Syndrome After Treatment With Continuous Positive Airway Pressure

France28 participantsStarted 2016-05

Plain-language summary

Published data indicate that obstructive sleep apnea syndrome (OSAS) worse the prognosis of coronary artery disease (CAD) and that oxidative stress can link this 2 diseases. Investigators hypothesise that oxidative stress decrease after 3 months of continuous positive airway pressure (CPAP) in this specific population. The results may have major implication in the comprehension of physiopathologic processes linking OSAS and CAD and in the treatment of OSAS in this specific population.

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: * Apnea Hypopnea Index 15-30/h * Stable Coronary artery disease * Obligation of obtaining informed consent form Exclusion Criteria: * Heart failure with LVEF less than or equal to 45% * Other Chronic disease: renal failure, COPD Index - central apneas than or equal to 50% of the total IAH * treatment with CPAP or mandibular advancement device * IMC\> 40 kg / m² * Nutritional supplementation in the 4 weeks preceding the study (antioxidants, vitamins ...). * Treatment with allopurinol or N-acetylcysteine, in the 4 weeks preceding the study. * PaCO2\> 45 mmHg - Counter-indication to the use of PPC: bullous lung disease, pathological hypotension, bypass airway, pneumothorax, signs of sinus infections or inner ear * Exclusion period on subject compared to another protocol or for which the maximum annual amount of compensation of € 4,500 has been reached. * Participation of the subject to another study. * Not affiliated with a social security scheme subject or not the beneficiary of such a regime. * Pregnant or breastfeeding women, patient unable to give consent, protected adult, vulnerable * Subject deprived of liberty by judicial or administrative decision * HIV infection, hepatitis B or hepatitis C known

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

Percentage change of serum GSH/GSSG ratio

Timeframe: at the inclusion and the end (3 months) of the study

Trial details

NCT IDNCT02893865

SponsorUniversity Hospital, Montpellier

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-07

View on ClinicalTrials.gov More Sleep Apnea Syndrome trials