Clinical trial NCT03421704: A Prospective Multicenter Registry of Patients With Sleep Disordered Breathing Treated With DreamStation BiPAP autoSV.
Official title: A Prospective Multicenter Registry of Patients With Sleep Disordered Breathing Treated With DreamStation BiPAP autoSV.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Central Sleep Apnea
Mixed Sleep Apnea
Cheyne-Stokes Respiration
Complex Sleep Apnea
Lead sponsor: Philips Respironics
Sponsor class: INDUSTRY
First posted: 2018-02-05
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The registry will include adult participants with indication and prescription of PR DS-autoSV

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).


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)

Primary outcomes:
measure: Short term Device usage and therapy adherence
timeFrame: 6 months
Secondary outcomes:
measure: Long term Device usage and therapy adherence
timeFrame: 12 months
measure: Change in Health-related quality of life
timeFrame: 6, 12 and 24 months
measure: Change in Subjective sleep quality
timeFrame: 6, 12 and 24 months
measure: Change in Daytime sleepiness.
timeFrame: 6, 12 and 24 months
measure: Change on PSG/PG Parameters from baseline
timeFrame: 6 months
measure: Change on PSG/PG Parameters from baseline
timeFrame: 6 months
measure: Mortality
timeFrame: 6, 12 and 24 months
measure: Causes of death
timeFrame: 6, 12 and 24 months
measure: Number of healthcare utilization
timeFrame: 6, 12 and 24 months
Other outcomes:
Locations:
city: Bad Oeynhausen
country: Germany
facility: Universitätsklinikum der Ruhr-Universität Bochum
city: Berlin
country: Germany
facility: Charité
city: Donaustauf
country: Germany
facility: Klinik Donaustauf
city: Hagen
country: Germany
facility: Helios Klinik Hagen Ambrok
city: Muenster
country: Germany
facility: Muenster University Hospital
city: Regensburg
country: Germany
facility: University Hospital Regensburg
city: Schmallenberg
country: Germany
facility: Fachkrankenhaus Kloster
city: Schwerin
country: Germany
facility: Helios Kliniken Schwerin
city: Solingen
country: Germany
facility: Wissenschaftliches Institut Bethanien für Pneumologie e.V
Study officials:
affiliation: University Hospital Regensburg
name: Michael Arzt, MD
role: PRINCIPAL_INVESTIGATOR
References: