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)

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure; Pulmonary Disease, Chronic Obstructive; Sleep-Disordered Breathing
• Intervention / Treatment: Procedure: polygraphy or polysomnography

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 Type: Observational
• Enrollment (Actual): 383

Contacts and Locations

Study Locations

• Denmark
  • Glostrup, Denmark, 2600
    • Danish Center for Sleep Medicine
• France
  • Grenoble, France, 38043
    • Centre Hospitalier Universitaire Grenoble Alpes, Pole Thorax et Vaisseaux (PTV), Clinique de Physiologie Sommeil et Exercice
• Germany
  • Berlin, Germany, 10117
    • Interdisziplinäres Schlafmedizinisches Zentrum, Charité Universitätsmedizin Berlin
  • Regensburg, Germany, 93053
    • Schlafmedizinisches Zentrum der Klinik und Polyklinik für Innere Medizin II, Pneumologie, Universitätsklinikum Regensburg
  • Solingen, Germany, 42699
    • Wissenschaftliches Institut Bethanien für Pneumologie e.V.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patient from primary care clinics and sleep medicine centers

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
SDB+COPD; Patients with sleep-disordered breathing and concomitant chronic obstructive pulmonary disease	Procedure: polygraphy or polysomnography
SDB+HF; Patients with sleep-disordered breathing and concomitant heart failure	Procedure: polygraphy or polysomnography
SDB+COPD+HF; Patients with sleep-disordered breathing and concomitant chronic obstructive pulmonary disease and heart failure	Procedure: polygraphy or polysomnography

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Wissenschaftliches Institut Bethanien e.V
• Collaborators: Philips Respironics

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2016
• Primary Completion (Actual): June 30, 2017
• Study Completion (Actual): June 30, 2017

Study Registration Dates

• First Submitted: September 30, 2016
• First Submitted That Met QC Criteria: October 3, 2016
• First Posted (Estimate): October 4, 2016

Study Record Updates

• Last Update Posted (Actual): October 29, 2018
• Last Update Submitted That Met QC Criteria: October 26, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Heart Failure; Sleep Apnea Syndromes; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: WI_COPD+HF+SDB_16-250

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No