About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial population
Subjects aged over 18, suffering from moderate to severe OSA and with CV pathology or at high risk of developing it.
Trial design
Case-control
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Compliance with MAD and CPAP at 6 months (wearing time).
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 outcomes
Assessment of oral status
plaque index : values from 0 to 3. A high score is a worse outcome.
Assessment of oral status
mobility index : values from 1 to 4. A high score is a worse outcome.
Assessment of oral status
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)
survey : values from 0 to 3. A high score is a better outcome.
Sponsors and contacts
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