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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)

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)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02923505
Enrollment
383
Registered
2016-10-04
Start date
2016-05-16
Completion date
2017-06-30
Last updated
2018-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

PROCEDUREpolygraphy or polysomnography

Sponsors

Philips Respironics
CollaboratorINDUSTRY
Wissenschaftliches Institut Bethanien e.V
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
All-cause Healthcare Costs2 years
Diagnosis-related Healthcare Costs2 years
Adherence to PAP therapy, (% days with usage >=4h/night)2 years

Countries

Denmark, France, Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026