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

• Conditions: G47.31; R06.3; Periodic breathing

• Registration Number: DRKS00013919
• Lead Sponsor: Philips

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-15
• Study Completion: 2023-04-20
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 125

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)

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Short term Device usage and therapy adherence [ Time Frame: 6 months ]<br>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. Patients are supposed to wear the device every night and therapy adherence data will be collected through device SD cards.