Evaluation of Prognostic Criteria for Observance of Continuous Positive Pressure for the Treatment of Obstructive Sleep Apnea Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Time (in minutes) for the daily use of the CPAP therapy
研究概览
简要总结
Moderate to severe obstructive sleep apnea syndrome (OSAS) (HAI hypopnea apnea index ≥ 15) is a common pathology, which affects 6 to 17% of the general population. The Alaska study, which involved 480,000 apneic patients newly fitted with CPAP, showed that 76.9% of patients were still under treatment for one year, 62.9% after two years, and 52.3% after three years.
All patients who recently diagnosed with OSAS in the Sleep Disorder Unit (unity de Pathologies du Sommeil et de la Vigilance, CHU d'AMIENS-PICARDIE, FRANCE) and who are requiring CPAP will be included. On the day of their hospitalization for the implementation of the CPAP therapy, patients will answer validated questionnaires to assess their level of motivation and adherence to the initiation of treatment but also to assess their knowledge and understanding of the disease and its treatment. These questionnaires will be repeated at the four-month and one-year follow-up consultations (+/- 21 days).
The aim of the study is to identify the prognostic factors of adherence to CPAP, leading to a better understanding and management of patients with sleep apnea syndrome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •Adult patient (≥ 18 years old)
- •Diagnosis of moderate to severe obstructive sleep apnea syndrome OSAS (AHI ≥ 15) by polygraphy or polysomnography performed in our Sleep disorder Unit
- •Requiring CPAP therapy
- •Informed consent
排除标准
- •Patient previously treated with CPAP therapy
- •Psychiatric illness destabilized
- •Unstable medical condition (i.e. COPD exacerbation, acute cardiac dysfunction, etc.)
- •Planned obesity or ENT surgery (because CPAP treatment is planned for a short period)
- •Central or mixed apnea syndrome
- •Patient under 18 years old
- •Pregnant, parturient or breastfeeding woman
- •Patient under guardianship, curators or deprived of liberty
- •Patient participating in another research including an exclusion period still in progress at the pre-inclusion.
结局指标
主要结局
Time (in minutes) for the daily use of the CPAP therapy
时间窗: at 4 months
次要结局
未报告次要终点