Central Sleep ApneaautoSVREGDENCT03421704
A Prospective Multicenter Registry of Patients With Sleep Disordered Breathing Treated With DreamStation BiPAP autoSV.
An observational study of Central Sleep Apnea and Mixed Sleep Apnea, run by Philips Respironics at 9 sites in Germany.
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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Central Sleep Apnea, Mixed Sleep Apnea, Cheyne-Stokes Respiration
- What is being tested?
- DreamStation BiPAP autoSV
- Type of treatment
- Medical device
- How many people
- 129 participants
- Where
- 9 sitesGermany
- Study dates
- 25 Jan 2018to 20 Apr 2023
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The registry will include adult participants with indication and prescription of PR DS-autoSV
Who may be able to join
- Indication and prescription of PR DS-autoSV
- Polysomnographic (PSG) or Polygraphic (PG) documentation of sleep-disordered breathing requiring servo ventilation
Who cannot join
- 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)
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- 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)
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Germany9 sites
Universitätsklinikum der Ruhr-Universität Bochum
Bad Oeynhausen
Charité
Berlin, 10117
Klinik Donaustauf
Donaustauf
Helios Klinik Hagen Ambrok
Hagen, 6058091
Muenster University Hospital
Münster
University Hospital Regensburg
Regensburg, 93053
Fachkrankenhaus Kloster
Schmallenberg
Helios Kliniken Schwerin
Schwerin, 19049
Wissenschaftliches Institut Bethanien für Pneumologie e.V
Solingen, 42699
About this study
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).
- Being tested
- DreamStation BiPAP autoSV
- Medical subject headings
- Sleep Apnea, Central, Sleep Apnea Syndromes, Cheyne-Stokes Respiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DreamStation BiPAP autoSVDevice
Philips Respironics DreamStation BiPAP autoSV (PR DS-autoSV) is designed to deliver pressure support for patient ventilatory assistance
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (9)
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.
Measured: 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
Measured: 6, 12 and 24 months
Change in Subjective sleep quality
Pittsburgh Sleep Quality Index (PSQI)
Measured: 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.
Measured: 6, 12 and 24 months
Change on PSG/PG Parameters from baseline
Disordered breathing events
Measured: 6 months
Change on PSG/PG Parameters from baseline
Quality of Sleep
Measured: 6 months
Mortality
Frequency of death in patients who showed adherence to therapy as compared to those with non-adherence
Measured: 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
Measured: 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)
Measured: 6, 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start25 Jan 2018
- Primary completion20 Apr 2023
- Study completion20 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 129 participants (actual)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Philips Respironics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Arzt, MD, Principal investigator, University Hospital Regensburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03421704
- Sponsor's protocol ID
- SRC-SLE-ASVREGDE-2017-10032
- Acronym
- autoSVREGDE
- Status last verified
- Sep 2023
- First submitted
- 10 Jan 2018
- Last updated
- 2 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicenter Registry of Patients With Sleep Disordered Breathing Treated With DreamStation BiPAP autoSV.
- ClinicalTrials.gov ID
- NCT03421704
- Acronym / sponsor ID
- autoSVREGDE / SRC-SLE-ASVREGDE-2017-10032
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Philips RespironicsIndustry (pharma, biotech, devices)
- Study start
- 25 Jan 2018 (actual)
- Primary completion
- 20 Apr 2023 (actual)
- Study completion
- 20 Apr 2023 (actual)
- First posted
- 5 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The registry will include adult participants with indication and prescription of PR DS-autoSV
Key inclusion criteria (2 listed)
- Indication and prescription of PR DS-autoSV
- Polysomnographic (PSG) or Polygraphic (PG) documentation of sleep-disordered breathing requiring servo ventilation
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DreamStation BiPAP autoSVPhilips Respironics DreamStation BiPAP autoSV (PR DS-autoSV) is designed to deliver pressure support for patient ventilatory assistance | Device | – |
Primary outcome
Short term Device usage and therapy adherence
Time frame: 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.
9 secondary outcomes
Long term Device usage and therapy adherence
Time frame: 12 months
Change in Health-related quality of life
Time frame: 6, 12 and 24 months
Change in Subjective sleep quality
Time frame: 6, 12 and 24 months
Change in Daytime sleepiness.
Time frame: 6, 12 and 24 months
Change on PSG/PG Parameters from baseline
Time frame: 6 months
Change on PSG/PG Parameters from baseline
Time frame: 6 months
Mortality
Time frame: 6, 12 and 24 months
Causes of death
Time frame: 6, 12 and 24 months
Number of healthcare utilization
Time frame: 6, 12 and 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2023.
- Individual participant dataSharing planned: No
Related trials for Central Sleep Apnea
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Orthognathic Surgery and Obstructive Sleep Apnea Assessed by Mandibular Jaw Movement Monitoring (SUNRISE-ORTHO)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Arzt, MD principal investigator
University Hospital Regensburg
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Central Sleep Apnea and Mixed Sleep Apnea, run by Philips Respironics at 9 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short term Device usage and therapy adherence (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2023.