A Prospective Multicenter Registry of Patients With Sleep Disordered Breathing Treated With DreamStation BiPAP autoSV.

Study Overview
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Brief Summary
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This multi-center observational study will prospectively collect data from patients who have an indication for servo ventilation therapy. This registry is intended to characterize the patient populations that may benefit from DreamStation BiPAP autoSV therapy (PR DS-autoSV, Philips Respironics, Monroeville, PA) in real life settings. In addition, this registry will assess adherence to the PR DS-autoSV therapy, the therapeutic benefits, collect morbidity and mortality data of servo ventilation in patients with central sleep apnea (CSA) and complex sleep-disordered breathing (SDB).

Official Title
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A Prospective Multicenter Registry of Patients With Sleep Disordered Breathing Treated With DreamStation BiPAP autoSV.

Conditions
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Central Sleep Apnea, Mixed Sleep Apnea, Cheyne-Stokes Respiration, Complex Sleep Apnea

Intervention / Treatment
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* Device: DreamStation BiPAP autoSV


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Indication and prescription of PR DS-autoSV Polysomnographic (PSG) or Polygraphic (PG) documentation of sleep-disordered breathing requiring servo ventilation Exclusion Criteria: Patients with HFrEF - heart failure and low ejection fraction (EF ≤ 45%) and predominant CSA (> 50 % of events) Patients not able to receive positive airway pressure support through a mask due to surgical procedure or anatomical condition Chronic conditions with life expectancy < 1 year Significant chronic obstructive pulmonary disease (COPD) with an FEV1/VC < 70% (GOLD III) Respiratory insufficiency requiring long-term oxygen therapy Daytime hypercapnia at rest (pCO2 > 45 mmHg) Cardiac surgery, PCI, myocardial infarction, unstable angina, within 12 weeks prior to enrolment Cardiac resynchronization or pacemaker implantation within the last 6 months Untreated or therapy refractory Restless legs-Syndrome (RLS)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: DreamStation BiPAP autoSV|Philips Respironics DreamStation BiPAP autoSV (PR DS-autoSV) is designed to deliver pressure support for patient ventilatory assistance|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short term Device usage and therapy adherence | Device usage (hours/ night). Patients will be classified into various adherence subgroups based on the average daily device use at each study interval. The percentage of participants in each of the adherence subgroups will be presented. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long term Device usage and therapy adherence | EDevice usage (hours/ night). Patients will be classified into various adherence subgroups based on the average daily device use at each study interval. The percentage of participants in each of the adherence subgroups will be presented. | 12 months | 
| Change in Health-related quality of life | European Quality of Life-5 Dimensions questionnaire EQ 5D- 5L) is a standardized instrument for measuring generic health related quality of life. This tools scores range from 1 to 5, with higher scores indicating more problems across five dimensions (5D) which comprise mobility, self-care, usual activities, pain/discomfort, and anxiety/depression | 6, 12 and 24 months | 
| Change in Subjective sleep quality | Pittsburgh Sleep Quality Index (PSQI) | 6, 12 and 24 months | 
| Change in Daytime sleepiness. | Epworth Sleepiness Scale (ESS). This test consists of eight questions of daily life activities with a number from 0 (not at all likely to fall asleep) to 3 (very likely to fall asleep) which yields a score of 0 to 24, and subjectively quantify sleepiness.25 An ESS score ranging from 0 to 10 is interpreted as normal, scores of 11 to 24 is considered to be abnormal and indicative of increasing levels of excessive daytime sleepiness. | 6, 12 and 24 months | 
| Change on PSG/PG Parameters from baseline | Disordered breathing events | 6 months | 
| Change on PSG/PG Parameters from baseline | Quality of Sleep | 6 months | 
| Mortality | Frequency of death in patients who showed adherence to therapy as compared to those with non-adherence | 6, 12 and 24 months | 
| Causes of death | causes of death , if available, will be compared in patients who showed adherence to therapy as compared to those with non-adherence | 6, 12 and 24 months | 
| Number of healthcare utilization | Number of hospitalizations during the minimum of one year follow-up, time to first hospitalization, composite number of unscheduled visits to emergency rooms and/or physician's office) in patients who showed adherence to therapy as compared to those with non-adherence (if data is available) | 6, 12 and 24 months |