Patients with Coronary Artery Disease or At High Cardiovascular Risk: Measuring Compliance with Treatment for Obstructive Sleep Apnea Syndrome

Launched by UNIVERSITY HOSPITAL, MONTPELLIER · Aug 20, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how well patients with coronary artery disease or those at high risk for heart problems comply with treatments for obstructive sleep apnea (OSA), a condition that can cause breathing interruptions during sleep. The main treatments being compared are Continuous Positive Airway Pressure (CPAP), which delivers a steady stream of air to keep the airway open, and a Mandibular Advancement Device (MAD), which is a mouthguard-like device that helps keep the airway open by repositioning the jaw. The trial aims to see how well patients tolerate these treatments and how effective they are, especially since many patients find CPAP uncomfortable.

To participate in this study, you need to be between the ages of 65 to 74 and have coronary artery disease or be at very high risk for developing it. This includes individuals with other health issues like high blood pressure or diabetes. If you have moderate to severe OSA and have had trouble using CPAP, you might be eligible to try the MAD device. Participants in the trial will receive either CPAP or MAD treatment and will be monitored throughout the study period to see how well they do with their assigned treatment. It's important to know that individuals with severe heart failure, certain psychiatric disorders, or who are pregnant cannot participate in this study.

Gender

ALL

Eligibility 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.