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

Philips Respironics129 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

129

Conditions

Central Sleep Apnea Mixed Sleep Apnea Cheyne-Stokes Respiration Complex Sleep Apnea

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 6 months

Secondary Outcomes

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.

Time frame: 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

Time frame: 6, 12 and 24 months

Change in Subjective sleep quality

Pittsburgh Sleep Quality Index (PSQI)

Time frame: 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.

Time frame: 6, 12 and 24 months

Change on PSG/PG Parameters from baseline

Disordered breathing events

Time frame: 6 months

Change on PSG/PG Parameters from baseline

Quality of Sleep

Time frame: 6 months

Mortality

Frequency of death in patients who showed adherence to therapy as compared to those with non-adherence

Time frame: 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

Time frame: 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)

Time frame: 6, 12 and 24 months