READ-ASV Registry - Phase II

Sleep Apnea Clinical Trial

— READ-ASV  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04331821
• Other study ID #: Protocol 2019-04-16
• Status: Recruiting
• Start date: May 1, 2019
• Est. completion date: July 31, 2021

Study information

• Verified date: April 2020
• Source: ResMed
• Contact: Oliver Munt, PhD
• Phone: +49 162 9056360
• Email: oliver.munt[@]resmed.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

The pilot phase (NCT03032029) enrolled over 200 patients now being analyzed. After completion of the the pilot phase the registry expands to 1 additional country in Europe with the goal of enrolling up to 700-1000 patients over a period of 5 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: July 31, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 110 Years

Eligibility

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.

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.

Related Conditions & MeSH terms

• Apnea
• Respiratory Aspiration
• Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Disorder
• Sleep Wake Disorders
• Sleep-disordered Breathing

Locations

Country	Name	City	State
Denmark	Odense Universitetshospital	Odense
Germany	Medizinisches Zentrum	Bad Lippspringe	Nordrhein-Westfalen
Germany	Praxis für Lunge, Herz und Schlaf	Bielefeld
Germany	Schlaf- und Beatmungszentrum Blaubeuren	Blaubeuren	Baden-Württemberg
Germany	Klinik für Schlafmedizin Düsseldorf Grand Arc	Dusseldorf	Nordrhein-Westfalen
Germany	Ruhrlandklinik Essen	Essen	Northrhine-Westphalia
Germany	Universitätsklinikum Heidelberg	Heidelberg	Baden-Württemberg
Germany	Lungenklinik Hemer	Hemer	Nordrhein-Westfalen
Germany	Evangelisches Krankenhaus Herne	Herne	Nordrhein-Westfalen
Germany	Praxis für Pneumologie, Allergologie, Schlafmedizin Dr. med Christoph Stolpe	Ibbenbüren	Nordrhein-Westfalen
Germany	Klinikum Karlsruhe	Karlsruhe	Baden-Württemberg
Germany	Klinik für Pneumologie, Schlaf- und Beatmungsmedizin	Kempten	Bayern
Germany	Klinikum Landshut	Landshut	Bayern
Germany	Klinikum Nürnberg-Med Klinik 3	Nürnberg	Bavaria
Germany	Universitätsklinikum Regensburg	Regensburg
Germany	Fachkrankenhaus Kloster Grafschaft	Schmallenberg	Nordrhein-Westfalen
Germany	Marienkrankenhaus Soest	Soest	Nordrhein-Westfalen
Germany	ZMS Zentrum für medizinische Studien	Warendorf	Nordrhein-Westfalen
Portugal	Hospital de Santa Maria	Lisboa
Portugal	Hospital Sao Joao	Porto
Spain	Hospital de Cruces	Baracaldo
Spain	Hospital Clinic	Barcelona
Switzerland	Inselspital	Bern
Switzerland	Centre d` investigation et de recherche sur le sommeil	Lausanne

Sponsors (2)

Lead Sponsor	Collaborator
ResMed	CRI-The Clinical Research Institute, Munich

Countries where clinical trial is conducted

Denmark,  Germany,  Portugal,  Spain,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Baseline to 12 months
Secondary	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).	Baseline to 12 months
Secondary	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 analysed in connection with the outcomes.	Baseline to 12 months
Secondary	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.	Baseline to 12 months
Secondary	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.	12 months