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)

October 26, 2018 updated by: Wissenschaftliches Institut Bethanien e.V
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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wissenschaftliches Institut Bethanien e.V

Collaborators

Philips Respironics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Other Study ID Numbers

  • WI_COPD+HF+SDB_16-250

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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