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

Completed

• Conditions: Mixed Sleep Apnea; Central Sleep Apnea; Cheyne-Stokes Respiration; Complex Sleep Apnea

• Registration Number: NCT03421704
• Lead Sponsor: Philips Respironics

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-10
• Study Start: 2018-01-25
• Study First Submitted QC: 2018-02-01
• Study First Posted: 2018-02-05
• Primary Completion: 2023-04-20
• Study Completion: 2023-04-20
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-29
• Last Update Posted: 2023-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 129

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Short term Device usage and therapy adherence	6 months	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.

Secondary Outcome Measures

Name	Time	Method
Long term Device usage and therapy adherence	12 months	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.
Change in Daytime sleepiness.	6, 12 and 24 months	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.
Change on PSG/PG Parameters from baseline	6 months	Quality of Sleep
Change in Subjective sleep quality	6, 12 and 24 months	Pittsburgh Sleep Quality Index (PSQI)
Change in Health-related quality of life	6, 12 and 24 months	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
Mortality	6, 12 and 24 months	Frequency of death in patients who showed adherence to therapy as compared to those with non-adherence
Causes of death	6, 12 and 24 months	causes of death , if available, will be compared in patients who showed adherence to therapy as compared to those with non-adherence
Number of healthcare utilization	6, 12 and 24 months	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)

Trial Locations

Locations (9)

Universitätsklinikum der Ruhr-Universität Bochum; 🇩🇪 Bad Oeynhausen, Germany

Charité; 🇩🇪 Berlin, Germany

University Hospital Regensburg; 🇩🇪 Regensburg, Germany

Helios Klinik Hagen Ambrok; 🇩🇪 Hagen, Germany

Muenster University Hospital; 🇩🇪 Muenster, Germany

Klinik Donaustauf; 🇩🇪 Donaustauf, Germany

Fachkrankenhaus Kloster; 🇩🇪 Schmallenberg, Germany

Helios Kliniken Schwerin; 🇩🇪 Schwerin, Germany

Wissenschaftliches Institut Bethanien für Pneumologie e.V; 🇩🇪 Solingen, Germany