NCT02923505

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)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 383 (actual)
• Sponsor: Wissenschaftliches Institut Bethanien e.V · Academic / Other
• Sex: All
• Age: 21 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sleep-Disordered Breathing
• Pulmonary Disease, Chronic Obstructive
• Heart Failure

Interventions

Type	Name	Description
PROCEDURE	polygraphy or polysomnography

Timeline

• Start date: 2016-05-16
• Primary completion: 2017-06-30
• Completion: 2017-06-30
• First posted: 2016-10-04
• Last updated: 2018-10-29

Locations

5 sites across 3 countries: Denmark, France, Germany