NCT Number: NCT02923505
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.
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Notify MeKey information
Conditions
Age range
21 year–75 year
Sex eligibility
All sexes
Study type
Observational
Primary location
Danish Center for Sleep Medicine, Glostrup Municipality, Denmark
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
All-cause Healthcare Costs
Time frame: 2 years
-
Diagnosis-related Healthcare Costs
Time frame: 2 years
-
Adherence to PAP therapy, (% days with usage >=4h/night)
Time frame: 2 years
Sponsors and collaborators
Lead sponsor
Wissenschaftliches Institut Bethanien e.V
Other
Collaborators
- Philips Respironics
Registry information
Important dates
- Study start
- 2016
- Primary completion
- 2017
- Study completion
- 2017
- First posted
- Oct 4, 2016
- Registry last updated
- Oct 29, 2018
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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