Registry on the Treatment of Central and Complex Sleep-Disordered Breathing With Adaptive Servo-V… (NCT03032029) | Clinical Trial Compass
CompletedNot Applicable
Registry on the Treatment of Central and Complex Sleep-Disordered Breathing With Adaptive Servo-Ventilation
Denmark, France, Germany847 participantsStarted 2017-09-05
Plain-language summary
Phase 1: The European ASV Registry (short name) will investigate the use of Adaptive Servo-Ventilation in non-heart failure conditions. The purpose is to examine the effects of ASV on quality of life, daytime symptoms and sleep, to describe usage patterns of ASV with regards to patient characteristics and to document adverse events related to therapy for a therapy safety analysis. A pilot phase will enrol at least 200 patients to test the feasibility of the registry. After the pilot phase will be completed and an intermediate data analysis had been performed, the registry will be expanded over several countries across Europe with the goal of enrolling up to 800 patients over a period of 5 years. Phase 2: The READ-ASV Registry (short name) will investigate the use of Adaptive Servo-Ventilation in non-heart failure conditions. The purpose is to examine the effects of ASV on quality of life, daytime symptoms and sleep, to describe usage patterns of ASV with regards to patient characteristics and to document adverse events related to therapy for a therapy safety analysis.
Who can participate
Age range
18 Years – 99 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients over ≥18 years of Age
* Prescription of ResMed AirCurve 10 CS PaceWave or S9 AutoSet CS PaceWave for treatment of ASV
* Naive to ASV Treatment
* Able to fully understand information on data protection and provide written informed consent
Exclusion Criteria:
\- Heart Failure (HF) with a Left Ventricular Ejection Fraction (LVEF) \<45% and CSA \>50% central apneas of all apneas
Phase 2: Inclusion Criteria:
* ≥ 18 years old.
* Indication for treatment with ASV according to applicable medical guidelines.
* Use of eligible ResMed devices for treatment with ASV according to the Instructions For Use of the corresponding device.
* Naive to ASV treatment (max. 7 days between start of ASV therapy and enrolment).
* Able to fully understand information on data protection and provide written informed consent for use of their medical data.
Phase 2: Exclusion Criteria:
* Chronic, symptomatic heart failure (NYHA 2-4) with reduced left ventricular ejection fraction (LVEF ≤ 45%) and moderate to severe predominant central sleep apnea.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Quality of Life, assessed with the Functional Outcomes of Sleep Questionnaire (FOSQ) by comparing the score at baseline with the 12 months follow-up.
Timeframe: 12 months
2
Phase 2: Quality of Life, assessed with the Functional Outcomes of Sleep Questionnaire (FOSQ) by comparing the score at baseline with the follow-up after 12 months.