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)

NCT02923505 | Completed

• 1 other identifier: WI_COPD+HF+SDB_16-250
• Study Type: observational
• Target: 383
• Locations: 3 countries
• Sites: 5

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• All-cause Healthcare Costs

  2 years

• Diagnosis-related Healthcare Costs

  2 years

• Adherence to PAP therapy, (% days with usage >=4h/night)

  2 years

Study Arms (3)

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

Interventions

polygraphy or polysomnography PROCEDURE

SDB+COPD; SDB+COPD+HF; SDB+HF

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patient from primary care clinics and sleep medicine centers

You may qualify if:

• 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

You may not qualify if:

• age \<21 or \>75 years

Sponsors & Collaborators

• Wissenschaftliches Institut Bethanien e.V: lead
• Philips Respironics: collaborator

Study Sites (5)

Danish Center for Sleep Medicine

Glostrup Municipality, 2600, Denmark

Location

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

Grenoble, 38043, France

Location

Interdisziplinäres Schlafmedizinisches Zentrum, Charité Universitätsmedizin Berlin

Berlin, 10117, Germany

Location

Schlafmedizinisches Zentrum der Klinik und Polyklinik für Innere Medizin II, Pneumologie, Universitätsklinikum Regensburg

Regensburg, 93053, Germany

Location

Wissenschaftliches Institut Bethanien für Pneumologie e.V.

Solingen, 42699, Germany

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes; Pulmonary Disease, Chronic Obstructive; Heart Failure

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Lung Diseases, Obstructive; Lung Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2016
• First Posted: October 4, 2016
• Study Start: May 16, 2016
• Primary Completion: June 30, 2017
• Study Completion: June 30, 2017
• Last Updated: October 29, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (3); DK (1); FR (1)