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 Overview
=================
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.

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)

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

Intervention / Treatment
-----------------
* Procedure: polygraphy or polysomnography


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| SDB+COPD<br>Patients with sleep-disordered breathing and concomitant chronic obstructive pulmonary disease | Procedure: polygraphy or polysomnography<br> <br> |
| SDB+HF<br>Patients with sleep-disordered breathing and concomitant heart failure | Procedure: polygraphy or polysomnography<br> <br> |
| SDB+COPD+HF<br>Patients with sleep-disordered breathing and concomitant chronic obstructive pulmonary disease and heart failure | Procedure: polygraphy or polysomnography<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause Healthcare Costs |  | 2 years | 
| Diagnosis-related Healthcare Costs |  | 2 years | 
| Adherence to PAP therapy, (% days with usage >=4h/night) |  | 2 years |