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临床试验/NCT02923505
NCT02923505已完成不适用

Effect of Positive Airway Pressure Therapy on Hospitalization and Mortality in SDB Patients With Comorbid Chronic Obstructive Pulmonary Disease (COPD) or/and Heart Failure (HF)

Wissenschaftliches Institut Bethanien e.V5 个研究点 分布在 3 个国家目标入组 383 人开始时间: 2016年5月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
383
试验地点
5
主要终点
All-cause Healthcare Costs

研究概览

简要总结

The aim of the study is to test the hypothesis that treatment of sleep disordered breathing (SDB) in patients with comorbid chronic obstructive pulmonary disease (COPD) and/or heart failure (HF) with positive airway pressure (PAP) is associated with reduced risk for hospitalizations and death, lower health care utilization, and greater cost-effectiveness.

详细描述

In this retrospective analysis the health care utilization in patients with COPD and HF will be quantified. Data of patients who additionally underwent a polysomnography or polygraphy between 2012 and 2015 are taken into consideration. The data (risk for hospitalization and death, comorbidities, diagnosis and therapy of SDB, costs of health care utilization) will be collected 12 months before and 12 months after diagnosis of SDB.

The patients' medical records will also be reviewed for compliance to treatment for SDB, and the patients will be classified as treated or untreated. The treated group will be divided into two subgroups: those with "good adherence" to PAP therapy (≥ 4 hours PAP use per night) and those with "poor adherence" to PAP therapy (< 4 hours PAP use per night). Healthcare Utilizations, HF or COPD exacerbations and mortality will be identified by reviewing medical records, National database when available, or self-reported by patient or patient's family through phone interview or questionnaire.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
21 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • subjects between 21 to 75 years;
  • consecutive patients who underwent polysomnography or polygraphy during the period of 01/01/2012 to 31/12/
  • diagnosis of COPD and/or HF

排除标准

  • age <21 or >75 years

结局指标

主要结局

All-cause Healthcare Costs

时间窗: 2 years

Diagnosis-related Healthcare Costs

时间窗: 2 years

Adherence to PAP therapy, (% days with usage >=4h/night)

时间窗: 2 years

次要结局

未报告次要终点

研究者

发起方
Wissenschaftliches Institut Bethanien e.V
申办方类型
Other
责任方
Sponsor

研究点 (5)

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