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

NCT03032029 | Completed

• 2 other identifiers: READ-ASV_Reg_Protoc_170404Protocol 2019-04-16
• Study Type: observational
• Target: 847
• Locations: 6 countries
• Sites: 29

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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.

  12 months

• 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).

  Baseline to 12 months

Secondary Outcomes (12)

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

  12 months

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

  12 months

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

  12 months

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

  6 months

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

  6 months

Interventions

Adaptive Servo-Ventilation DEVICE

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

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• \- Heart Failure (HF) with a Left Ventricular Ejection Fraction (LVEF) \<45% and CSA \>50% central apneas of all apneas
• ≥ 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.
• Chronic, symptomatic heart failure (NYHA 2-4) with reduced left ventricular ejection fraction (LVEF ≤ 45%) and moderate to severe predominant central sleep apnea.

Sponsors & Collaborators

• ResMed: lead
• CRI-The Clinical Research Institute GmbH: collaborator
• University Hospital Regensburg: collaborator

Study Sites (29)

Sjællands Universitetshospital/Zealand University Hospital Køge

Køge, Denmark

Location

Odense Universitetshospital

Odense, 5000, Denmark

Location

Centre Hospitalier Universitaire Grenoble Alpes

Grenoble, 38043, France

Location

Schlaf- und Beatmungszentrum

Blaubeuren Abbey, Baden-Wurttemberg, 89143, Germany

Location

Universitätsklinikum Heidelberg

Heidelberg, Baden-Wurttemberg, 69126, Germany

Location

Klinikum Karlsruhe

Karlsruhe, Baden-Wurttemberg, 76133, Germany

Location

Klinik für Pneumologie, Schlaf- und Beatmungsmedizin

Kempten (Allgäu), Bavaria, 87439, Germany

Location

Klinikum Landshut

Landshut, Bavaria, 84034, Germany

Location

Klinikum Nürnberg-Med Klinik 3

Nuremberg, Bavaria, 90419, Germany

Location

University Hospital Regensburg

Regensburg, Bavaria, 93053, Germany

Location

Medizinisches Zentrum

Bad Lippspringe, North Rhine-Westphalia, 33175, Germany

Location

Praxis für Lunge, Herz und Schlaf

Bielefeld, North Rhine-Westphalia, 33617, Germany

Location

Christophorus Kliniken

Dülmen, North Rhine-Westphalia, 48249, Germany

Location

Klinik für Schlafmedizin Düsseldorf Grand Arc

Düsseldorf, North Rhine-Westphalia, 40235, Germany

Location

Ruhrlandklinik Essen

Essen, North Rhine-Westphalia, 45239, Germany

Location

Lungenklinik Hemer

Hemer, North Rhine-Westphalia, 58675, Germany

Location

Evangelisches Krankenhaus Herne

Herne, North Rhine-Westphalia, 44623, Germany

Location

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

Ibbenbueren, North Rhine-Westphalia, 49477, Germany

Location

Fachkrankenhaus Kloster Grafschaft

Schmallenberg, North Rhine-Westphalia, 57392, Germany

Location

Marienkrankenhaus Soest

Soest, North Rhine-Westphalia, 59494, Germany

Location

ZMS Zentrum für medizinische Studien

Warendorf, North Rhine-Westphalia, 48231, Germany

Location

Universitätsklinikum SH

Lübeck, Schleswig-Holstein, 23538, Germany

Location

Hospital de Santa Maria

Lisbon, Portugal

Location

Hospital Sao Joao

Porto, Portugal

Location

Hospital de Cruces

Barakaldo, Spain

Location

Hospital Clinic

Barcelona, Spain

Location

Hospital General de Asturias

Oviedo, Spain

Location

Inselspital

Bern, 3010, Switzerland

Location

Centre d' investigation et de recherche sur le sommeil

Lausanne, 1011, Switzerland

Location

Related Publications (4)

• 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.

  PMID: 37077553 BACKGROUND

• 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.

  PMID: 38241012 BACKGROUND

• 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.

  PMID: 40359269 DERIVED

• 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.

  PMID: 40135691 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Central; Sleep Apnea Syndromes; Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2017
• First Posted: January 26, 2017
• Study Start: September 5, 2017
• Primary Completion: June 30, 2022
• Study Completion: July 1, 2022
• Last Updated: October 16, 2024

Record last verified: 2024-01

Locations

DE (19); ES (3); PT (2); CH (2); DK (2); FR (1)