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

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).

Study Overview

• Status: Completed
• Conditions: Cheyne-Stokes Respiration; Central Sleep Apnea; Mixed Sleep Apnea; Complex Sleep Apnea
• Intervention / Treatment: Device: DreamStation BiPAP autoSV

• Study Type: Observational
• Enrollment (Actual): 129

Contacts and Locations

Study Locations

• Germany
  • Bad Oeynhausen, Germany
    • Universitätsklinikum der Ruhr-Universität Bochum
  • Berlin, Germany, 10117
    • Charité
  • Donaustauf, Germany
    • Klinik Donaustauf
  • Hagen, Germany, 6058091
    • Helios Klinik Hagen Ambrok
  • Muenster, Germany
    • Muenster University Hospital
  • Regensburg, Germany, 93053
    • University Hospital Regensburg
  • Schmallenberg, Germany
    • Fachkrankenhaus Kloster
  • Schwerin, Germany, 19049
    • Helios Kliniken Schwerin
  • Solingen, Germany, 42699
    • Wissenschaftliches Institut Bethanien für Pneumologie e.V

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Long term Device usage and therapy adherence	EDevice 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.	12 months
Change in Health-related quality of life	European Quality of Life-5 Dimensions questionnaire EQ 5D- 5L) is a standardized instrument for measuring generic health related quality of life. This tools scores range from 1 to 5, with higher scores indicating more problems across five dimensions (5D) which comprise mobility, self-care, usual activities, pain/discomfort, and anxiety/depression	6, 12 and 24 months
Change in Subjective sleep quality	Pittsburgh Sleep Quality Index (PSQI)	6, 12 and 24 months
Change in Daytime sleepiness.	Epworth Sleepiness Scale (ESS). This test consists of eight questions of daily life activities with a number from 0 (not at all likely to fall asleep) to 3 (very likely to fall asleep) which yields a score of 0 to 24, and subjectively quantify sleepiness.25 An ESS score ranging from 0 to 10 is interpreted as normal, scores of 11 to 24 is considered to be abnormal and indicative of increasing levels of excessive daytime sleepiness.	6, 12 and 24 months
Change on PSG/PG Parameters from baseline	Disordered breathing events	6 months
Change on PSG/PG Parameters from baseline	Quality of Sleep	6 months
Mortality	Frequency of death in patients who showed adherence to therapy as compared to those with non-adherence	6, 12 and 24 months
Causes of death	causes of death , if available, will be compared in patients who showed adherence to therapy as compared to those with non-adherence	6, 12 and 24 months
Number of healthcare utilization	Number of hospitalizations during the minimum of one year follow-up, time to first hospitalization, composite number of unscheduled visits to emergency rooms and/or physician's office) in patients who showed adherence to therapy as compared to those with non-adherence (if data is available)	6, 12 and 24 months

Collaborators and Investigators

• Sponsor: Philips Respironics
• Investigators: Principal Investigator: Michael Arzt, MD, University Hospital Regensburg

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2018
• Primary Completion (Actual): April 20, 2023
• Study Completion (Actual): April 20, 2023

Study Registration Dates

• First Submitted: January 10, 2018
• First Submitted That Met QC Criteria: February 1, 2018
• First Posted (Actual): February 5, 2018

Study Record Updates

• Last Update Posted (Actual): October 2, 2023
• Last Update Submitted That Met QC Criteria: September 29, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Apnea; Cheyne-Stokes Respiration; Sleep Apnea, Central
• Other Study ID Numbers: SRC-SLE-ASVREGDE-2017-10032

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes