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A Prospective Multicenter Registry of Patients With Sleep Disordered Breathing Treated With DreamStation BiPAP autoSV. | Clinical Trials | Clareo Health

COMPLETED

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

NCT03421704•Philips Respironics

View on ClinicalTrials.gov

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

Age

18 - 99 years

Sex

ALL

Healthy Volunteers

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)

Locations (9)

Universitätsklinikum der Ruhr-Universität Bochum

Bad Oeynhausen, Germany

Charité

Berlin, Germany

Klinik Donaustauf

Donaustauf, Germany

Helios Klinik Hagen Ambrok

Hagen, Germany

Muenster University Hospital

Münster, Germany

University Hospital Regensburg

Regensburg, Germany

Fachkrankenhaus Kloster

Schmallenberg, Germany

Helios Kliniken Schwerin

Schwerin, Germany

Wissenschaftliches Institut Bethanien für Pneumologie e.V

Solingen, Germany

Key Dates

Start Date

January 25, 2018

Primary Completion Date

April 20, 2023

Completion Date

April 20, 2023

Last Updated

October 2, 2023

Enrollment

129

ACTUAL participants

Conditions

Central Sleep ApneaMixed Sleep ApneaCheyne-Stokes RespirationComplex Sleep Apnea

Interventions

DreamStation BiPAP autoSV

DEVICE

Belgian Central Sleep Apnea REgistry

NCT03621566

Central Sleep Apnea

View study

COMPLETEDPHASE2

Managing Opioid Related Sleep Apnea With Acetazolamide

NCT06043830

Sleep-Disordered BreathingObstructive Sleep Apnea+3 more

View study

TERMINATEDNA

Pathophysiological Study of CSA in Adults With pLVEF

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 2, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Belgian Central Sleep Apnea REgistry

Managing Opioid Related Sleep Apnea With Acetazolamide

Pathophysiological Study of CSA in Adults With pLVEF

Post Approval Study of the remedē System

Effect of Heart Valve Replacement on Cheyne-Stokes Respiration

Comparison of SomnaPatch With Polysomnography in Sleep Disordered Breathing