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)

Completed

• Conditions: Sleep-Disordered Breathing; Heart Failure; Pulmonary Disease, Chronic Obstructive
• Interventions: Procedure: polygraphy or polysomnography

• Registration Number: NCT02923505
• Lead Sponsor: Wissenschaftliches Institut Bethanien e.V

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.

Study Timeline

• Study Start: 2016-05-16
• Study First Submitted: 2016-09-30
• Study First Submitted QC: 2016-10-03
• Study First Posted: 2016-10-04
• Primary Completion: 2017-06-30
• Study Completion: 2017-06-30
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-26
• Last Update Posted: 2018-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 383

Inclusion Criteria

• subjects between 21 to 75 years;
• consecutive patients who underwent polysomnography or polygraphy during the period of 01/01/2012 to 31/12/2015.
• diagnosis of COPD and/or HF

Exclusion Criteria

• age <21 or >75 years

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SDB+COPD	polygraphy or polysomnography	Patients with sleep-disordered breathing and concomitant chronic obstructive pulmonary disease
SDB+COPD+HF	polygraphy or polysomnography	Patients with sleep-disordered breathing and concomitant chronic obstructive pulmonary disease and heart failure
SDB+HF	polygraphy or polysomnography	Patients with sleep-disordered breathing and concomitant heart failure

Primary Outcome Measures

Name	Time	Method
All-cause Healthcare Costs	2 years
Diagnosis-related Healthcare Costs	2 years
Adherence to PAP therapy, (% days with usage >=4h/night)	2 years

Trial Locations

Locations (5)

Schlafmedizinisches Zentrum der Klinik und Polyklinik für Innere Medizin II, Pneumologie, Universitätsklinikum Regensburg; 🇩🇪 Regensburg, Germany

Centre Hospitalier Universitaire Grenoble Alpes, Pole Thorax et Vaisseaux (PTV), Clinique de Physiologie Sommeil et Exercice; 🇫🇷 Grenoble, France

Interdisziplinäres Schlafmedizinisches Zentrum, Charité Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany

Wissenschaftliches Institut Bethanien für Pneumologie e.V.; 🇩🇪 Solingen, Germany

Danish Center for Sleep Medicine; 🇩🇰 Glostrup, Denmark