Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:23 PM
Ignite Modification Date:
2025-12-24 @ 2:23 PM
NCT ID:
NCT06568159
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06568159
Study Brief:
Protocol Section:
NCT06568159