NCT03421704

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
129

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2018

Longer than P75 for all trials

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2018

Completed
15 days until next milestone

Study Start

First participant enrolled

January 25, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 5, 2018

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2023

Completed
Last Updated

October 2, 2023

Status Verified

September 1, 2023

Enrollment Period

5.2 years

First QC Date

January 10, 2018

Last Update Submit

September 29, 2023

Conditions

Central Sleep ApneaMixed Sleep ApneaCheyne-Stokes RespirationComplex Sleep Apnea

Outcome Measures

Primary Outcomes (1)

  • Short term Device usage and therapy adherence

    Device usage (hours/ night). Patients will be classified into various adherence subgroups based on the average daily device use at each study interval. The percentage of participants in each of the adherence subgroups will be presented.

    6 months

Secondary Outcomes (9)

  • Long term Device usage and therapy adherence

    12 months

  • Change in Health-related quality of life

    6, 12 and 24 months

  • Change in Subjective sleep quality

    6, 12 and 24 months

  • Change in Daytime sleepiness.

    6, 12 and 24 months

  • Change on PSG/PG Parameters from baseline

    6 months

  • +4 more secondary outcomes

Interventions

DreamStation BiPAP autoSVDEVICE

Philips Respironics DreamStation BiPAP autoSV (PR DS-autoSV) is designed to deliver pressure support for patient ventilatory assistance

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The registry will include adult participants with indication and prescription of PR DS-autoSV

You may qualify if:

  • Indication and prescription of PR DS-autoSV
  • Polysomnographic (PSG) or Polygraphic (PG) documentation of sleep-disordered breathing requiring servo ventilation

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Universitätsklinikum der Ruhr-Universität Bochum

Bad Oeynhausen, Germany

Location

Charité

Berlin, 10117, Germany

Location

Klinik Donaustauf

Donaustauf, Germany

Location

Helios Klinik Hagen Ambrok

Hagen, 6058091, Germany

Location

Muenster University Hospital

Münster, Germany

Location

University Hospital Regensburg

Regensburg, 93053, Germany

Location

Fachkrankenhaus Kloster

Schmallenberg, Germany

Location

Helios Kliniken Schwerin

Schwerin, 19049, Germany

Location

Wissenschaftliches Institut Bethanien für Pneumologie e.V

Solingen, 42699, Germany

Location

MeSH Terms

Conditions

Sleep Apnea, CentralSleep Apnea SyndromesCheyne-Stokes Respiration

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Michael Arzt, MD

    University Hospital Regensburg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
24 Months
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2018

First Posted

February 5, 2018

Study Start

January 25, 2018

Primary Completion

April 20, 2023

Study Completion

April 20, 2023

Last Updated

October 2, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

DE(9)