A Prospective Multicenter Registry of Patients With Sleep Disordered Breathing Treated With DreamStation BiPAP autoSV.
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Central Sleep Apnea
- Sponsor
- Philips Respironics
- Enrollment
- 129
- Locations
- 9
- Primary Endpoint
- Short term Device usage and therapy adherence
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
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).
Investigators
Eligibility Criteria
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)
Outcomes
Primary Outcomes
Short term Device usage and therapy adherence
Time Frame: 6 months
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.
Secondary Outcomes
- Long term Device usage and therapy adherence(12 months)
- Change in Daytime sleepiness.(6, 12 and 24 months)
- Change on PSG/PG Parameters from baseline(6 months)
- Change in Subjective sleep quality(6, 12 and 24 months)
- Change in Health-related quality of life(6, 12 and 24 months)
- Mortality(6, 12 and 24 months)
- Causes of death(6, 12 and 24 months)
- Number of healthcare utilization(6, 12 and 24 months)