A Prospective Multicenter Registry of Patients With Sleep Disordered Breathing Treated With Dream… (NCT03421704) | Clinical Trial Compass
CompletedNot Applicable
A Prospective Multicenter Registry of Patients With Sleep Disordered Breathing Treated With DreamStation BiPAP autoSV.
Germany129 participantsStarted 2018-01-25
Plain-language 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).
Who can participate
Age range18 Years – 99 Years
SexALL
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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)