Patients with Coronary Artery Disease or At High Cardiovascular Risk: Measuring Compliance
Obstructive sleep apnea (OSA) is a sleep disorder characterised by partial or total obstruction of the oro-pharyngeal carrefour during sleep. It is found in between 4% and 25% of the general population and in 40 to 80% of patients with cardiovascular diseases. Continuous positive airway pressure (CPAP) is the standard
| Condition(s) | Obstructive Sleep Apnea, Coronary Disease, Cardiovascular Diseases |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | Obstructive sleep apnea (OSA) is a sleep disorder characterised by partial or total obstruction of the oro-pharyngeal carrefour during sleep. It is found in between 4% and 25% of the general population and in 40 to 80% of patients with cardiovascular diseases. Continuous positive airway pressure (CPAP) is the standard treatment for OSA and its efficacy has already been demonstrated in this particular population. However, this treatment is not always accepted or sufficiently tolerated. The mandibular advancement device (MAD) is therefore an alternative treatment for OSA, validated by the French National Authority for Health and particularly relevant in this population because it is generally better tolerated. The aim of our study was to assess compliance, tolerance and usability of CPAP and |
| Who can participate | 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 treat |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | University Hospital, Montpellier |
| Locations | Montpellier, France |
| Start date | 2025-02-14 |
| NCT ID | NCT06568159 |
| Official listing | https://clinicaltrials.gov/study/NCT06568159 |