Patients with Coronary Artery Disease or At High Cardiovascular Risk: Measuring Compliance with Treatment for Obstructive Sleep Apnea Syndrome (OAM or CPAP)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Compliance with MAD and CPAP at 6 months (wearing time).
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Compliance with MAD and CPAP at 6 months (wearing time).
时间窗: 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).
次要结局
- Assessment of oral status(the day of inclusion)
- Assessment of tolerance and satisfaction with the device used reported by the patient at 6 months (duration of wear)(6 months post-inclusion)
- Clinical parameters of OSA (objective)(6 months post-inclusion)
- Assessment of quality of life(6 months post-inclusion)
- Clinical parameters of OSA (subjective)(6 months post-inclusion)