NCT06568159Recruiting
Patients with Coronary Artery Disease or At High Cardiovascular Risk: Measuring Compliance with Treatment for Obstructive Sleep Apnea Syndrome
Patients with Coronary Artery Disease or At High Cardiovascular Risk: Measuring Compliance with Treatment for Obstructive Sleep Apnea Syndrome (OAM or CPAP)
Source: ClinicalTrials.gov · Last updated 18 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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 MAD in patients with coronary artery disease and moderate (Apnea-Hypopnea Index AHI 15-30) to severe (AHI\>30) OSA.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 60 (estimated)
- First submitted
- 26 Jul 2024
- Start date
- 14 Feb 2025
- Primary completion date
- 14 Feb 2026
- Lead sponsor
- University Hospital, Montpellier
- Diseases
- Coronary artery disease
- NCT number
- NCT06568159
What you commit to
- Study type: Observational
- Planned participants: 60
- From 14 Feb 2025 to the primary completion date, 14 Feb 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients with heart failure not stabilised according to the investigator (NYHA IV)
- Severe psychiatric disorders
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU de Montpellier Coordinator of this site? Confirm its status | Montpellier | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.