跳至主要内容
临床试验/NCT04894175
NCT04894175已完成不适用

Association Between Treatment Perception and Treatment Adherence in Obstructive Sleep Apnea Patients Treated by Continuous Positive Airway Pressure (SEMSAS Study)

Thibaut Gentina1 个研究点 分布在 1 个国家目标入组 302 人开始时间: 2021年5月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
302
试验地点
1
主要终点
Continuous positive airway pressure adherence

研究概览

简要总结

The objective of the study is to define an optimal threshold of the SEMSA-15 scale for obstructive sleep apnea (OSA) perception in patients with OSA to predict 3-month and 1-year continuous positive airway pressure adherence.

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

入选标准

  • Obstructive Sleep apnea diagnosed, whatever the initial severity and treated with CPAP
  • Voluntary patient
  • patient in the national healthcare insurance system

排除标准

  • Patient with central sleep apnea
  • Treatment other than CPAP
  • Person with liberty privation or under legal protection

结局指标

主要结局

Continuous positive airway pressure adherence

时间窗: 1-year

To define an optimal threshold for the Self-efficacy Measure for Sleep Apnea (SEMSA-15) scale to predict 1-year CPAP adherence

次要结局

  • To study the impact of patient quality of life on CPAP adherence(3-month and 1-year)
  • to assess the improvement of quality of life according to health litteracy and precariousness(1-year)
  • To construct an overall predictive model of CPAP adherence(3-month and 1-year)
  • To assess the interactions between CPAP adherence trajectories and patients parameters(3-month and 1-year)
  • To study the impact of health litteracy on CPAP adherence(3-month and 1-year)
  • To study the impact of precariousness on CPAP adherence(3-month and 1-year)
  • To compute an overall score to predict CPAP adherence(3-month and 1-year)
  • Define patient phenotype according all collected variables(At inclusion)

研究者

申办方类型
Industry
责任方
Sponsor Investigator
主要研究者

Thibaut Gentina

Principal investigator

Auxilair

研究点 (1)

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