AzTrials
AzTrials

Central Sleep ApneaREAD-ASVNCT03032029

Registry on the Treatment of Central and Complex Sleep-Disordered Breathing With Adaptive Servo-Ventilation

An observational study of Central Sleep Apnea and Complex Sleep Apnea, run by ResMed at 29 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 99 years
What is being tested?
Adaptive Servo-Ventilation
Type of treatment
Medical device
How many people
847 participants
Where
29 sitesin 6 countries
Study dates
5 Sep 2017to 1 Jul 2022
How long will I take part?
12 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 shall include adult individuals with a prescription of ASV therapy. Indications are sleep-related breathing disorders, including obstructive, central or complex sleep apnea.

Who may be able to join

  • 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

Who cannot join

  • 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).
Show all 9Show fewer
  • 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.

Trial locations and contacts

29 sites in 6 countries.

29 sites in 6 countries

Germany19 sites

  • Medizinisches Zentrum

    Bad Lippspringe, North Rhine-Westphalia, 33175

  • Praxis für Lunge, Herz und Schlaf

    Bielefeld, North Rhine-Westphalia, 33617

  • Schlaf- und Beatmungszentrum

    Blaubeuren Abbey, Baden-Wurttemberg, 89143

  • Christophorus Kliniken

    Dülmen, North Rhine-Westphalia, 48249

  • Klinik für Schlafmedizin Düsseldorf Grand Arc

    Düsseldorf, North Rhine-Westphalia, 40235

  • Ruhrlandklinik Essen

    Essen, North Rhine-Westphalia, 45239

  • Universitätsklinikum Heidelberg

    Heidelberg, Baden-Wurttemberg, 69126

  • Lungenklinik Hemer

    Hemer, North Rhine-Westphalia, 58675

  • Evangelisches Krankenhaus Herne

    Herne, North Rhine-Westphalia, 44623

  • Praxis für Pneumologie, Allergologie, Schlafmedizin Dr. med Christoph Stolpe

    Ibbenbueren, North Rhine-Westphalia, 49477

  • Klinikum Karlsruhe

    Karlsruhe, Baden-Wurttemberg, 76133

  • Klinik für Pneumologie, Schlaf- und Beatmungsmedizin

    Kempten (Allgäu), Bavaria, 87439

  • Klinikum Landshut

    Landshut, Bavaria, 84034

  • Universitätsklinikum SH

    Lübeck, Schleswig-Holstein, 23538

  • Klinikum Nürnberg-Med Klinik 3

    Nuremberg, Bavaria, 90419

  • University Hospital Regensburg

    Regensburg, Bavaria, 93053

  • Fachkrankenhaus Kloster Grafschaft

    Schmallenberg, North Rhine-Westphalia, 57392

  • Marienkrankenhaus Soest

    Soest, North Rhine-Westphalia, 59494

  • ZMS Zentrum für medizinische Studien

    Warendorf, North Rhine-Westphalia, 48231

Other trials in Germany

Spain3 sites

  • Hospital de Cruces

    Barakaldo

  • Hospital Clinic

    Barcelona

  • Hospital General de Asturias

    Oviedo

Other trials in Spain

Denmark2 sites

  • Sjællands Universitetshospital/Zealand University Hospital Køge

    Køge

  • Odense Universitetshospital

    Odense, 5000

Other trials in Denmark

Portugal2 sites

  • Hospital de Santa Maria

    Lisbon

  • Hospital Sao Joao

    Porto

Other trials in Portugal

Switzerland2 sites

  • Inselspital

    Bern, 3010

  • Centre d' investigation et de recherche sur le sommeil

    Lausanne, 1011

Other trials in Switzerland

France1 site

  • Centre Hospitalier Universitaire Grenoble Alpes

    Grenoble, 38043

Other trials in France

About this study

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.

Read the detailed description

Phase 1: The collection of data will be performed during the course of clinical routine. In regular clinical practice, a first control visit (i.e. Follow-up number one) should occur during the first 6 months. Further follow-up visits are only indicated when the patient is reporting problems during the course of therapy. We recommend FU visit at least once year (after the first routine FU visit). Each patient will be included for 6 months, the total duration of phase 1 of the registry. Phase 2: The pilot phase 1 enrolled over 200 patients. After completion of the pilot phase the registry expands to 1 additional country in Europe with the goal of enrolling up to 800 patients over a period of 4 years. The collection of data will be performed during the course of clinical routine. In regular clinical practice, a first control visit (i.e. Follow-up number one) should occur after the first 12 months of therapy use. Further follow-up visits are only indicated when the patient is reporting problems during the course of therapy. Each patient will be included for a maximum of 15 months, whereas serious events will be tracked throughout the total duration of phase I and II of the registry.

Being tested
Adaptive Servo-Ventilation
Medical subject headings
Sleep Apnea, Central, Sleep Apnea Syndromes, Sleep Apnea, Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Adaptive Servo-VentilationDevice

    Adaptive Bi-Level positive airway pressure with a targeted minute ventilation and auto-adjusting expiratory pressure level.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    The Functional Outcomes of Sleep Questionnaire had been developed to comprehensively capture the impact of sleeping disorders in relevant daily activities as for instance general activity, vigilance, intimacy, fitness and social life.

    Measured: 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.

    The Functional Outcomes of Sleep Questionnaire had been developed to comprehensively capture the impact of sleeping disorders in relevant daily activities as for instance general activity, vigilance, intimacy, fitness and social life. The FOSQ consists of 30 questions, answer options ranging from 4 (no problems) to 1(severe problems) or 0(not applicable) adding up to a total score between 5(worst functional status)-20(best functional status).

    Measured: Baseline to 12 months

Secondary outcomes (12)

  1. Daytime symptoms assessed with the EuroQoL (EQ-5D) by comparing the answers at baseline with answers at the follow-up at 12 months.

    The EQ-5D is a standardized questionnaire used to measure the health of patients. It is applicable in a large number of conditions and treatments and provides a simple descriptive profile and a single index value to define a state of health (mobility, self-care ability, activities, discomfort, anxiety).

    Measured: 12 months

  2. Daytime sleepiness assessed with the Epworth Sleepiness Scale (ESS) by comparing the score at baseline with the follow-up after 12 months.

    The Epworth or Epworth Sleepiness Scale questionnaire assesses excessive daytime sleepiness. It determines the probability of falling asleep in the context of 8 common situations in daily life. The patient self assesses, on a level of 0 to 3, drowsiness over the past few weeks. The maximum total score is 24.

    Measured: 12 months

  3. Quality of Sleep assessed with the Pittsburgh Sleep Quality Index (PSQI) at baseline compared with the follow-up after 12 months.

    The PSQI includes 19 self-assessment questions and 5 questions asked to the spouse or roommate (if any).The 19 self-assessment questions combine to give 7 components of the overall score, with each component receiving a score of 0-3.

    A score of 0 indicates that there is no difficulty while a score of 3 indicates the existence of severe difficulties. The 7 components of the score add up to give an overall score ranging from 0 to 21 points, 0 meaning that there is no difficulty, and 21 indicating difficulties.

    Measured: 12 months

  4. Therapy compliance assessed by the hours of usage per night.

    Usually, compliance is defined as device usage of ˃4h/night in ˃70% of nights to see effects on the Status of health. However, a usage of ≥ 3 hours might improve a patient's outcome: Data on úsage of ASV and outcomes is scarce. Since the aim of the study is to assess compliance, the data of the device has to be carefully analysed in connection with the outcomes.

    Measured: 6 months

  5. Apnea-Hypopnea-Index assessed by the number of Apneas and hypopneas per hour.

    The number of apneas and hypopneas per hour will be counted during the total time of sleep of a Patient, added up and divided by the hours of sleep. The result is an index, which indicates mild sleep apnea (AHI between 5-15 Events/hour), moderate sleep apnea (15-30 Events per hour) or severe sleep apnea (more than 30 Events per hour).

    Measured: 6 months

  6. Central Apnea Index assessed by the number of central apneas per hour.

    The number of central apneas - where the respiratory effort stops - per hour will be counted during the total time of sleep of a patient, added up and divided by the hours of sleep. The result is an index, which indicates mild central sleep apnea (AHI below 5 Events/hour), moderate central sleep apnea (5-15 Events per hour) or severe central sleep apnea (more than 15 Events per hour).

    Measured: 6 months

  7. Safety of ASV therapy assessed by documenting the number of adverse Events and the number of hospitalizations at the Overall end of the study.

    Adverse Events of Special Interest (e.g. Skin irritation or wound, Skin rashes, Conjunctivitis, Dryness of the upper airways, Therapy intolerance (pressure), Mask issues, leaks,Technical problems of the device) will be document as well as the number of Hospital stays during the study period.

    Measured: 6 months

  8. Phase 2: Daytime symptoms assessed with the EuroQoL (EQ-5D) by comparing the answers at baseline with answers at the follow-up at 12 months.

    The EuroQoL-5Dimension is a standardized questionnaire used to measure the health of patients. It is applicable in a large number of conditions and treatments. It defines 5 health-states: mobility, self-care ability, activities, discomfort, anxiety. The states of health will be described by rating them from 1(no problems) to 5 (extreme problems). The outcomes can either be displayed as mean (+/-SD) or percentages of patients rating their health state with a certain score. The combined 5 heath-states rating (e.g.11111, 12345 etc.) may be converted to a single index value (index value calculator must be ordered from the manufacturer. The EQ-5D comprises a visual analogue scale ranging from 0=worst health to 100=best health.

    Measured: Baseline to 12 months

  9. Phase 2: Daytime sleepiness assessed with the Epworth Sleepiness Scale (ESS) by comparing the score at baseline with the follow-up after 12 months.

    The Epworth or Epworth Sleepiness Scale questionnaire assesses excessive daytime sleepiness. It determines the probability of falling asleep in the context of 8 common situations in daily life. The patient self-assesses, on a level of 0 to 3, drowsiness over the past few weeks. The maximum total score is 24 (worst level of daytime sleepiness).

    Measured: Baseline to 12 months

  10. Phase 2: Therapy compliance assessed by the hours of usage per night.

    Usually, compliance is defined as device usage of ˃4h/night in ˃70% of nights to see effects on the Status of health. However, a usage of ≥ 3 hours might improve a patient's outcome: Data on usage of ASV and outcomes is scarce. Since the aim of the study is to assess compliance, the data of the device has to be carefully analyzed in connection with the outcomes.

    Measured: Baseline to 12 months

  11. Phase 2: Rate of hospitalizations for cardiovascular or respiratory cause per year of follow-up.

    All unplanned hospitalizations will be recorded as serious adverse events and assessed for cause of hospitalisation: cardiovascular or respiratory cause.

    Measured: 12 months

  12. Phase 2: Rate of all-cause deaths per year of follow-up.

    All deaths will be recorded. Cause of death will be assessed through the documentation in the study centers.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2017 (estimated)
  2. Study start5 Sep 2017
  3. Primary completion30 Jun 2022
  4. Study completion1 Jul 2022

Resources

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
847 participants (actual)
Target duration
12 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT03032029
Sponsor's protocol ID
READ-ASV_Reg_Protoc_170404
Other IDs
Protocol 2019-04-16
Acronym
READ-ASV
Status last verified
Jan 2024
First submitted
16 Jan 2017
Last updated
16 Oct 2024
Results posted
No
Data monitoring committee
No

Publications

  • Arzt M, Munt O, Pepin JL, Heinzer R, Kubeck R, von Hehn U, Ehrsam-Tosi D, Benjafield A, Woehrle H. Registry on the Treatment of Central and Complex Sleep-Disordered Breathing with Adaptive Servo-Ventilation (READ-ASV): protocol and cohort profile. ERJ Open Res. 2023 Apr 17;9(2):00618-2022. doi: 10.1183/23120541.00618-2022. eCollection 2023 Mar.

    PubMed 37077553

  • Arzt M, Munt O, Pepin JL, Heinzer R, Kubeck R, von Hehn U, Ehrsam-Tosi D, Benjafield AV, Woehrle H. Effects of Adaptive Servo-Ventilation on Quality of Life: The READ-ASV Registry. Ann Am Thorac Soc. 2024 Apr;21(4):651-657. doi: 10.1513/AnnalsATS.202310-908OC.

    PubMed 38241012

  • Pepin JL, Heinzer R, Bailly S, Lavergne F, Benjafield AV, Fischer S, Woehrle H, Arzt M. Clinical profile of responders to adaptive servo-ventilation: a cluster analysis from the READ-ASV European cohort. Sleep Med. 2026 Oct;146:109085. doi: 10.1016/j.sleep.2026.109085. Epub 2026 Jun 13.

    PubMed 42296895

  • Arzt M, Munt O, Kuebeck R, Woehrle H, Heinzer R, Benjafield AV, Pepin JL. Adaptive Servo-Ventilation for Treatment-Emergent Central Sleep Apnea: The READ-ASV Registry. Ann Am Thorac Soc. 2025 Oct;22(10):1546-1553. doi: 10.1513/AnnalsATS.202502-210OC.

    PubMed 40359269

  • Pepin JL, Benjafield AV, Munt O, Woehrle H, Heinzer R, Arzt M; READ-ASV Investigators. Treatment of sleep-disordered breathing in opioid users with adaptive servo-ventilation: a subgroup analysis of the European READ-ASV registry. J Clin Sleep Med. 2025 Jul 1;21(7):1227-1232. doi: 10.5664/jcsm.11652.

    PubMed 40135691

Questions about this trial

What is this clinical trial studying?

An observational study of Central Sleep Apnea and Complex Sleep Apnea, run by ResMed at 29 sites in 6 countries.

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 4 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 16 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in Germany, Spain, Denmark, Portugal, Switzerland and 1 more country. 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?

Quality of Life, assessed with the Functional Outcomes of Sleep Questionnaire (FOSQ) by comparing the score at baseline with the 12 months follow-up. (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03032029, which also lists 5 linked publications.

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 16 Oct 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in