Measuring treatment compliance for sleep apnea in heart disease patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• CHU de MONTPELLIER
  Montpellier, France Recruiting

Study contacts

• Study coordinator: Cindy FRANCOIS
• Email: c-francois@chu-montpellier.fr
• Phone: 06 84 31 62 08

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.