Long-term Benefits of Continuous Positive Pressure Therapy or Mandibular Advancement Devise on the Sleep of Patients With Obstructive Sleep Apnea
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- ResMed
- 入组人数
- 400
- 试验地点
- 9
- 主要终点
- To determine the evolution of deep slow-wave sleep at one year in OSA patients according to the treatment initiated by continuous positive pressure or mandibular advancement device (MAD).
研究概览
简要总结
The REMAP study aims to follow a cohort of 400 patients in around ten sleep centers in France and to collect clinical routine data. The objectives of this study are to investigate the effects of one-year management of OSA by CPAP or MAD on sleep architecture defined by objective macro and micro sleep architecture parameters using a sleep test device. sleep connected at home, to assess the quality of sleep and the quality of life reported by patients. The study will also allow us to define predictive factors for improving sleep quality during OSA treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient already included in the SunSAS study (No. ID/RCB: 2021-A01827-34) or Patient who has undergone polygraphy or polysomnography eligible for treatment with CPAP or MAD in the context of OSA.
- •Patient with a sleep test performed with the Sunrise device
- •Men or Women from 18 to 80 years old
- •Patient with OSAS eligible for CPAP or MAD therapy
- •Affiliated patient or beneficiary of a social security scheme
- •Signed informed consent
排除标准
- •Patient previously treated for OSAS by CPAP or MAD during the last five years
- •Patient with COPD or other respiratory diseases.
- •Patient with contraindications to PPC or MAD therapy
- •Patient with unstable heart disease or New York Heart Association class III or IV heart failure
- •Patient unable to complete the study
结局指标
主要结局
To determine the evolution of deep slow-wave sleep at one year in OSA patients according to the treatment initiated by continuous positive pressure or mandibular advancement device (MAD).
时间窗: 12 months
Objective evolution of deep slow-wave sleep time. Changes collected with a home-connected sleep testing device by comparing data from the initial visit (diagnosis) with data collected at 12 months (± 2 weeks) in a patient treated with CPAP or MAD.
次要结局
未报告次要终点