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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)

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ClinicalTrials.gov Identifier: NCT02923505
Recruitment Status : Completed
First Posted : October 4, 2016
Last Update Posted : October 29, 2018
Sponsor:
Collaborator:
Philips Respironics
Information provided by (Responsible Party):
Wissenschaftliches Institut Bethanien e.V

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.

Condition or disease Intervention/treatment
Sleep-Disordered Breathing Pulmonary Disease, Chronic Obstructive Heart Failure Procedure: polygraphy or polysomnography

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.

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Study Type : Observational
Actual Enrollment : 383 participants
Observational Model: Cohort
Time Perspective: Retrospective
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)
Actual Study Start Date : May 16, 2016
Actual Primary Completion Date : June 30, 2017
Actual Study Completion Date : June 30, 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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



Primary Outcome Measures :
  1. All-cause Healthcare Costs [ Time Frame: 2 years ]
  2. Diagnosis-related Healthcare Costs [ Time Frame: 2 years ]
  3. Adherence to PAP therapy, (% days with usage >=4h/night) [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patient from primary care clinics and sleep medicine centers
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02923505


Locations
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Denmark
Danish Center for Sleep Medicine
Glostrup, Denmark, 2600
France
Centre Hospitalier Universitaire Grenoble Alpes, Pole Thorax et Vaisseaux (PTV), Clinique de Physiologie Sommeil et Exercice
Grenoble, France, 38043
Germany
Interdisziplinäres Schlafmedizinisches Zentrum, Charité Universitätsmedizin Berlin
Berlin, Germany, 10117
Schlafmedizinisches Zentrum der Klinik und Polyklinik für Innere Medizin II, Pneumologie, Universitätsklinikum Regensburg
Regensburg, Germany, 93053
Wissenschaftliches Institut Bethanien für Pneumologie e.V.
Solingen, Germany, 42699
Sponsors and Collaborators
Wissenschaftliches Institut Bethanien e.V
Philips Respironics

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Responsible Party: Wissenschaftliches Institut Bethanien e.V
ClinicalTrials.gov Identifier: NCT02923505    
Other Study ID Numbers: WI_COPD+HF+SDB_16-250
First Posted: October 4, 2016    Key Record Dates
Last Update Posted: October 29, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Sleep Apnea Syndromes
Heart Failure
Heart Diseases
Cardiovascular Diseases
Respiratory Tract Diseases
Respiration Disorders
Apnea
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases