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Clinical Trials/NCT02923505
NCT02923505
Completed
Not Applicable

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 sites in 3 countries383 target enrollmentMay 16, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sleep-Disordered Breathing
Sponsor
Wissenschaftliches Institut Bethanien e.V
Enrollment
383
Locations
5
Primary Endpoint
All-cause Healthcare Costs
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
May 16, 2016
End Date
June 30, 2017
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Wissenschaftliches Institut Bethanien e.V
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • age \<21 or \>75 years

Outcomes

Primary Outcomes

All-cause Healthcare Costs

Time Frame: 2 years

Diagnosis-related Healthcare Costs

Time Frame: 2 years

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

Time Frame: 2 years

Study Sites (5)

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