Patients with Coronary Artery Disease or At High Cardiovascular Risk: Measuring Compliance with Treatment for Obstructive Sleep Apnea Syndrome
- Conditions
- Cardiovascular DiseasesCoronary DiseaseObstructive Sleep Apnea
- Registration Number
- NCT06568159
- Lead Sponsor
- University Hospital, Montpellier
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Compliance with MAD and CPAP at 6 months (wearing time). 6 months post-inclusion MAD compliance at 6 months (wearing time): a sleep diary will be given to the patient at the inclusion visit.
CPAP compliance at 6 months: data transmitted by the CPAP device (sleep diary).
- Secondary Outcome Measures
Name Time Method Assessment of oral status the day of inclusion bleeding index : values from 0 to 1 (100%). A high score is a worse outcome.
Assessment of tolerance and satisfaction with the device used reported by the patient at 6 months (duration of wear) 6 months post-inclusion survey : values from 0 to 3. A high score is a better outcome.
Clinical parameters of OSA (objective) 6 months post-inclusion ventilatory polygraphy or polysomnography
Assessment of quality of life 6 months post-inclusion Survey WHOQOL Bref. Values : very poor, poor, neither poor nor good, good, very good.
Clinical parameters of OSA (subjective) 6 months post-inclusion Survey. Values : light, moderate, significant
Trial Locations
- Locations (1)
CHU de MONTPELLIER
🇫🇷Montpellier, France