Clinical trial 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)
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep-Disordered Breathing
Pulmonary Disease, Chronic Obstructive
Heart Failure
Lead sponsor: Wissenschaftliches Institut Bethanien e.V
Sponsor class: OTHER
Collaborators: name: Philips Respironics
First posted: 2016-10-04
Enrollment: 383
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient from primary care clinics and sleep medicine centers

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.

Eligibility criteria: 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

Primary outcomes:
measure: All-cause Healthcare Costs
timeFrame: 2 years
measure: Diagnosis-related Healthcare Costs
timeFrame: 2 years
measure: Adherence to PAP therapy, (% days with usage >=4h/night)
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Danish Center for Sleep Medicine
city: Grenoble
country: France
facility: Centre Hospitalier Universitaire Grenoble Alpes, Pole Thorax et Vaisseaux (PTV), Clinique de Physiologie Sommeil et Exercice
city: Berlin
country: Germany
facility: Interdisziplinäres Schlafmedizinisches Zentrum, Charité Universitätsmedizin Berlin
city: Regensburg
country: Germany
facility: Schlafmedizinisches Zentrum der Klinik und Polyklinik für Innere Medizin II, Pneumologie, Universitätsklinikum Regensburg
city: Solingen
country: Germany
facility: Wissenschaftliches Institut Bethanien für Pneumologie e.V.
Study officials:
References: