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

NCT ID: NCT03032029

Last Updated: 2024-10-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 847 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-09-05
• Study Completion Date: 2022-07-01

Brief 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.

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.

Conditions

Central Sleep Apnea; Complex Sleep Apnea; Obstructive Sleep Apnea; Mixed Sleep Apnea

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Adaptive Servo-Ventilation

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

Intervention Type: DEVICE

Eligibility Criteria

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

• ≥ 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.

Exclusion Criteria

• Heart Failure (HF) with a Left Ventricular Ejection Fraction (LVEF) <45% and CSA >50% central apneas of all apneas

• Chronic, symptomatic heart failure (NYHA 2-4) with reduced left ventricular ejection fraction (LVEF ≤ 45%) and moderate to severe predominant central sleep apnea.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CRI-The Clinical Research Institute GmbH

INDUSTRY

Sponsor Role: collaborator

University Hospital Regensburg

OTHER

Sponsor Role: collaborator

ResMed

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sjællands Universitetshospital/Zealand University Hospital Køge

Køge, , Denmark

Odense Universitetshospital

Odense, , Denmark

Centre Hospitalier Universitaire Grenoble Alpes

Grenoble, , France

Schlaf- und Beatmungszentrum

Blaubeuren Abbey, Baden-Wurttemberg, Germany

Universitätsklinikum Heidelberg

Heidelberg, Baden-Wurttemberg, Germany

Klinikum Karlsruhe

Karlsruhe, Baden-Wurttemberg, Germany

Klinik für Pneumologie, Schlaf- und Beatmungsmedizin

Kempten (Allgäu), Bavaria, Germany

Klinikum Landshut

Landshut, Bavaria, Germany

Klinikum Nürnberg-Med Klinik 3

Nuremberg, Bavaria, Germany

University Hospital Regensburg

Regensburg, Bavaria, Germany

Medizinisches Zentrum

Bad Lippspringe, North Rhine-Westphalia, Germany

Praxis für Lunge, Herz und Schlaf

Bielefeld, North Rhine-Westphalia, Germany

Christophorus Kliniken

Dülmen, North Rhine-Westphalia, Germany

Klinik für Schlafmedizin Düsseldorf Grand Arc

Düsseldorf, North Rhine-Westphalia, Germany

Ruhrlandklinik Essen

Essen, North Rhine-Westphalia, Germany

Lungenklinik Hemer

Hemer, North Rhine-Westphalia, Germany

Evangelisches Krankenhaus Herne

Herne, North Rhine-Westphalia, Germany

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

Ibbenbueren, North Rhine-Westphalia, Germany

Fachkrankenhaus Kloster Grafschaft

Schmallenberg, North Rhine-Westphalia, Germany

Marienkrankenhaus Soest

Soest, North Rhine-Westphalia, Germany

ZMS Zentrum für medizinische Studien

Warendorf, North Rhine-Westphalia, Germany

Universitätsklinikum SH

Lübeck, Schleswig-Holstein, Germany

Hospital de Santa Maria

Lisbon, , Portugal

Hospital Sao Joao

Porto, , Portugal

Hospital de Cruces

Barakaldo, , Spain

Hospital Clinic

Barcelona, , Spain

Hospital General de Asturias

Oviedo, , Spain

Inselspital

Bern, , Switzerland

Centre d' investigation et de recherche sur le sommeil

Lausanne, , Switzerland

Countries

Denmark; France; Germany; Portugal; Spain; Switzerland

References

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.

Reference Type: BACKGROUND

PMID: 37077553 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 38241012 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 40359269 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 40135691 (View on PubMed)

Other Identifiers

Protocol 2019-04-16

Identifier Type: OTHER

Identifier Source: secondary_id

READ-ASV_Reg_Protoc_170404

Identifier Type: -

Identifier Source: org_study_id

NCT04331821

Identifier Type: -

Identifier Source: nct_alias