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

Central Sleep Apnea Clinical Trial

— autoSVREGDE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03421704
• Other study ID #: SRC-SLE-ASVREGDE-2017-10032
• Status: Completed
• Start date: January 25, 2018
• Est. completion date: April 20, 2023

Study information

• Verified date: September 2023
• Source: Philips Respironics
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: April 20, 2023
• Est. primary completion date: April 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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)

Related Conditions & MeSH terms

• Apnea
• Central Sleep Apnea
• Cheyne-Stokes Respiration
• Complex Sleep Apnea
• Mixed Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Central

Intervention

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

Locations

Country	Name	City	State
Germany	Universitätsklinikum der Ruhr-Universität Bochum	Bad Oeynhausen
Germany	Charité	Berlin
Germany	Klinik Donaustauf	Donaustauf
Germany	Helios Klinik Hagen Ambrok	Hagen
Germany	Muenster University Hospital	Muenster
Germany	University Hospital Regensburg	Regensburg
Germany	Fachkrankenhaus Kloster	Schmallenberg
Germany	Helios Kliniken Schwerin	Schwerin
Germany	Wissenschaftliches Institut Bethanien für Pneumologie e.V	Solingen

Sponsors (1)

Lead Sponsor	Collaborator
Philips Respironics

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Change in Subjective sleep quality	Pittsburgh Sleep Quality Index (PSQI)	6, 12 and 24 months
Secondary	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
Secondary	Change on PSG/PG Parameters from baseline	Disordered breathing events	6 months
Secondary	Change on PSG/PG Parameters from baseline	Quality of Sleep	6 months
Secondary	Mortality	Frequency of death in patients who showed adherence to therapy as compared to those with non-adherence	6, 12 and 24 months
Secondary	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
Secondary	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