Measuring treatment compliance for sleep apnea in heart disease patients
Patients with Coronary Artery Disease or At High Cardiovascular Risk: Measuring Compliance with Treatment for Obstructive Sleep Apnea Syndrome (OAM or CPAP)
This study tests how well heart disease patients with sleep apnea stick to using two different treatments, a CPAP machine and a mouthpiece, to see which one they find easier to use.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Montpellier Academic / other |
| Locations | 1 site (Montpellier) |
| Trial ID | NCT06568159 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the compliance, tolerance, and usability of two treatments for obstructive sleep apnea (OSA) in patients with coronary artery disease or those at high cardiovascular risk. The study compares the standard continuous positive airway pressure (CPAP) therapy with a mandibular advancement device (MAD), which may be better tolerated by patients. Participants will include those with moderate to severe OSA, and the study will evaluate how well they adhere to these treatments. The findings could provide insights into the effectiveness of these therapies in a high-risk population.
Who should consider this trial
Good fit: Ideal candidates include patients with coronary artery disease or at high cardiovascular risk who have moderate to severe obstructive sleep apnea.
Not a fit: Patients with unstable heart failure or severe psychiatric disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment adherence and outcomes for patients with obstructive sleep apnea and coronary artery disease.
How similar studies have performed: Previous studies have shown that alternative treatments like MAD can be effective for patients who struggle with CPAP, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Target population: with coronary artery disease or at very high risk of coronary artery disease: * Patients with coronary artery disease with or without co-morbidities (smoking, diabetes, hypertension, dyslipidaemia, renal insufficiency, overweight, emerging factors including anxiety-depression, shift workers, etc.). * Hypertensive patients at high cardiovascular risk (target organ damage such as LVH or albuminuria) * Diabetic patients at high cardiovascular risk * Type of heart disease: ischaemic heart disease without clinically significant heart failure (NYHA II, III, IV) For the experimental group (MAD): patients with moderate or severe OSA with intolerance or refusal of CPAP and managed by MAD. For the control group (CPAP): patients with moderate or severe OSA treated with CPAP. Exclusion Criteria: * Patients with heart failure not stabilised according to the investigator (NYHA IV) * Severe psychiatric disorders * Pregnant or breast-feeding women * Opposition to participation after a period of reflection * Not affiliated to a social security scheme, * Persons under court protection, * Persons under guardianship or curatorship * Person taking part in another study with an exclusion period still in progress * Inability to follow the patient during the study period.
Where this trial is running
Montpellier
- CHU de MONTPELLIER — Montpellier, France (Recruiting)
Study contacts
- Study coordinator: Cindy FRANCOIS
- Email: c-francois@chu-montpellier.fr
- Phone: 06 84 31 62 08
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.