Status:
COMPLETED
A Prospective Multicenter Registry of Patients With Sleep Disordered Breathing Treated With DreamStation BiPAP autoSV.
Lead Sponsor:
Philips Respironics
Conditions:
Central Sleep Apnea
Mixed Sleep Apnea
Eligibility:
All Genders
18-99 years
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 populati...
Eligibility Criteria
Inclusion
- Indication and prescription of PR DS-autoSV
- Polysomnographic (PSG) or Polygraphic (PG) documentation of sleep-disordered breathing requiring servo ventilation
Exclusion
- 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)
Key Trial Info
Start Date :
January 25 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 20 2023
Estimated Enrollment :
129 Patients enrolled
Trial Details
Trial ID
NCT03421704
Start Date
January 25 2018
End Date
April 20 2023
Last Update
October 2 2023
Active Locations (9)
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1
Universitätsklinikum der Ruhr-Universität Bochum
Bad Oeynhausen, Germany
2
Charité
Berlin, Germany, 10117
3
Klinik Donaustauf
Donaustauf, Germany
4
Helios Klinik Hagen Ambrok
Hagen, Germany, 6058091