Clinical trial NCT03032029: Registry on the Treatment of Central and Complex Sleep-Disordered Breathing With Adaptive Servo-Ventilation
Official title: Registry on the Treatment of Central and Complex Sleep-Disordered Breathing With Adaptive Servo-Ventilation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Central Sleep Apnea
Complex Sleep Apnea
Obstructive Sleep Apnea
Mixed Sleep Apnea
Lead sponsor: ResMed
Sponsor class: INDUSTRY
Collaborators: name: CRI-The Clinical Research Institute GmbH
name: University Hospital Regensburg
First posted: 2017-01-26
Enrollment: 847
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

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.

Primary outcomes:
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.
timeFrame: 12 months
measure: 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.
timeFrame: Baseline to 12 months
Secondary outcomes:
measure: Daytime symptoms assessed with the EuroQoL (EQ-5D) by comparing the answers at baseline with answers at the follow-up at 12 months.
timeFrame: 12 months
measure: Daytime sleepiness assessed with the Epworth Sleepiness Scale (ESS) by comparing the score at baseline with the follow-up after 12 months.
timeFrame: 12 months
measure: Quality of Sleep assessed with the Pittsburgh Sleep Quality Index (PSQI) at baseline compared with the follow-up after 12 months.
timeFrame: 12 months
measure: Therapy compliance assessed by the hours of usage per night.
timeFrame: 6 months
measure: Apnea-Hypopnea-Index assessed by the number of Apneas and hypopneas per hour.
timeFrame: 6 months
measure: Central Apnea Index assessed by the number of central apneas per hour.
timeFrame: 6 months
measure: Safety of ASV therapy assessed by documenting the number of adverse Events and the number of hospitalizations at the Overall end of the study.
timeFrame: 6 months
measure: 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.
timeFrame: Baseline to 12 months
measure: Phase 2: Daytime sleepiness assessed with the Epworth Sleepiness Scale (ESS) by comparing the score at baseline with the follow-up after 12 months.
timeFrame: Baseline to 12 months
measure: Phase 2: Therapy compliance assessed by the hours of usage per night.
timeFrame: Baseline to 12 months
measure: Phase 2: Rate of hospitalizations for cardiovascular or respiratory cause per year of follow-up.
timeFrame: 12 months
measure: Phase 2: Rate of all-cause deaths per year of follow-up.
timeFrame: 12 months
Other outcomes:
Locations:
city: Køge
country: Denmark
facility: Sjællands Universitetshospital/Zealand University Hospital Køge
city: Odense
country: Denmark
facility: Odense Universitetshospital
city: Grenoble
country: France
facility: Centre Hospitalier Universitaire Grenoble Alpes
city: Blaubeuren
country: Germany
facility: Schlaf- und Beatmungszentrum
state: Baden-Württemberg
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg
state: Baden-Württemberg
city: Karlsruhe
country: Germany
facility: Klinikum Karlsruhe
state: Baden-Württemberg
city: Nürnberg
country: Germany
facility: Klinikum Nürnberg-Med Klinik 3
state: Bavaria
city: Kempten
country: Germany
facility: Klinik für Pneumologie, Schlaf- und Beatmungsmedizin
state: Bayern
city: Landshut
country: Germany
facility: Klinikum Landshut
state: Bayern
city: Regensburg
country: Germany
facility: University Hospital Regensburg
state: Bayern
city: Bad Lippspringe
country: Germany
facility: Medizinisches Zentrum
state: Nordrhein-Westfalen
city: Bielefeld
country: Germany
facility: Praxis für Lunge, Herz und Schlaf
state: Nordrhein-Westfalen
city: Dülmen
country: Germany
facility: Christophorus Kliniken
state: Nordrhein-Westfalen
city: Düsseldorf
country: Germany
facility: Klinik für Schlafmedizin Düsseldorf Grand Arc
state: Nordrhein-Westfalen
city: Essen
country: Germany
facility: Ruhrlandklinik Essen
state: Nordrhein-Westfalen
city: Hemer
country: Germany
facility: Lungenklinik Hemer
state: Nordrhein-Westfalen
city: Herne
country: Germany
facility: Evangelisches Krankenhaus Herne
state: Nordrhein-Westfalen
city: Ibbenbüren
country: Germany
facility: Praxis für Pneumologie, Allergologie, Schlafmedizin Dr. med Christoph Stolpe
state: Nordrhein-Westfalen
city: Schmallenberg
country: Germany
facility: Fachkrankenhaus Kloster Grafschaft
state: Nordrhein-Westfalen
city: Soest
country: Germany
facility: Marienkrankenhaus Soest
state: Nordrhein-Westfalen
city: Warendorf
country: Germany
facility: ZMS Zentrum für medizinische Studien
state: Nordrhein-Westfalen
city: Lübeck
country: Germany
facility: Universitätsklinikum SH
state: Schleswig-Holstein
city: Lisbon
country: Portugal
facility: Hospital de Santa Maria
city: Porto
country: Portugal
facility: Hospital Sao Joao
city: Barakaldo
country: Spain
facility: Hospital de Cruces
city: Barcelona
country: Spain
facility: Hospital Clinic
city: Oviedo
country: Spain
facility: Hospital General de Asturias
city: Bern
country: Switzerland
facility: Inselspital
city: Lausanne
country: Switzerland
facility: Centre d' investigation et de recherche sur le sommeil
Study officials:
References:
citation: 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.
citation: 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.