Skip to main content
Clinical Trials/DRKS00013919
DRKS00013919
Completed
N/A

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

Philips0 sites125 target enrollmentMarch 15, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
G47.31
Sponsor
Philips
Enrollment
125
Status
Completed
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 15, 2018
End Date
April 20, 2023
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Philips

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

Not specified

Similar Trials