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)

Heart Failure Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02923505
• Other study ID #: WI_COPD+HF+SDB_16-250
• Status: Completed
• Start date: May 16, 2016
• Est. completion date: June 30, 2017

Study information

• Verified date: October 2018
• Source: Wissenschaftliches Institut Bethanien e.V
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 383
• Est. completion date: June 30, 2017
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• polygraphy or polysomnography

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Wissenschaftliches Institut Bethanien e.V	Philips Respironics

Countries where clinical trial is conducted

Denmark,  France,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause Healthcare Costs		2 years
Primary	Diagnosis-related Healthcare Costs		2 years
Primary	Adherence to PAP therapy, (% days with usage >=4h/night)		2 years