Evaluation of Compliance With CPAP Therapy in Patients Diagnosed With Obstructive Sleep Apnea Syndrome at the Hospital de Sabadell
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 405
- 试验地点
- 1
- 主要终点
- Ratio of patients with compliance with the treatment
研究概览
简要总结
The aim of the study is to know the adherence to treatment and compliance of patients diagnosed with SAHS and with indication of CPAP from the sleep unit of the Hospital de Sabadell.
详细描述
The investigatror's objective will be to know the adherence to treatment and compliance of patients diagnosed with SAHS and with indication of CPAP of the sleep unit of the Hospital de Sabadell. Is a cohort study. The dependent variables are adherence to treatment (% patients who continue using CPAP one year after initiation of treatment) and objective compliance with treatment (defined as use of ≥4h / night). For a confidence level of 95%, a sample of 405 patients was recruited, recruited consecutively at a rate of 33 patients per month among those diagnosed with SAHS and those indicated with CPAP treatment. This number foresees a possible abandonment rate of 5%. For the statistical analysis of the data related to compliance with the therapy and compliance with the follow-up process, descriptive analysis of the data with means, median and 95% CI, or percentages with 95% CI. For the statistical analysis of the factors influencing compliance: multivariate logistic regression.
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 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years of age treated with CPAP based on the diagnosis of OSAS (clinical picture and AHI> 10).
排除标准
- •Diagnosis of a psychiatric illness or dementia.
- •Communication problems or inability to read and speak Spanish.
结局指标
主要结局
Ratio of patients with compliance with the treatment
时间窗: 1 year after starting treatment
% of patients use CPAP ≥4h / night
Adherence rate to CPAP treatment
时间窗: 1 year after starting treatment
% of patients who still use CPAP
次要结局
未报告次要终点
研究者
Montserrat Montaña
Principal Investigator, Clinical Research
Corporacion Parc Tauli
