Status:
RECRUITING
Patients with Coronary Artery Disease or At High Cardiovascular Risk: Measuring Compliance with Treatment for Obstructive Sleep Apnea Syndrome
Lead Sponsor:
University Hospital, Montpellier
Conditions:
Obstructive Sleep Apnea
Coronary Disease
Eligibility:
All Genders
18+ years
Brief 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 populatio...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 14 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 15 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06568159
Start Date
February 14 2025
End Date
February 15 2026
Last Update
February 18 2025
Active Locations (1)
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1
CHU de MONTPELLIER
Montpellier, France, 34090