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

Obstructive 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: Completed

Administrative data

• NCT number: NCT03032029
• Other study ID #: READ-ASV_Reg_Protoc_170404
• Secondary ID: Protocol 2019-04
• Status: Completed
• Start date: September 5, 2017
• Est. completion date: July 1, 2022

Study information

• Verified date: January 2024
• Source: ResMed
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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 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.

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.

Other known NCT identifiers

• NCT04331821

Recruitment information / eligibility

• Status: Completed
• Enrollment: 847
• Est. completion date: July 1, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Apnea
• Central Sleep Apnea
• Complex Sleep Apnea
• Mixed Sleep Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Central
• Sleep Apnea, Obstructive

Intervention

Device:
• Adaptive Servo-Ventilation
Adaptive Bi-Level positive airway pressure with a targeted minute ventilation and auto-adjusting expiratory pressure level.

Locations

Country	Name	City	State
Denmark	Sjællands Universitetshospital/Zealand University Hospital Køge	Køge
Denmark	Odense Universitetshospital	Odense
France	Centre Hospitalier Universitaire Grenoble Alpes	Grenoble
Germany	Medizinisches Zentrum	Bad Lippspringe	Nordrhein-Westfalen
Germany	Praxis für Lunge, Herz und Schlaf	Bielefeld	Nordrhein-Westfalen
Germany	Schlaf- und Beatmungszentrum	Blaubeuren	Baden-Württemberg
Germany	Christophorus Kliniken	Dülmen	Nordrhein-Westfalen
Germany	Klinik für Schlafmedizin Düsseldorf Grand Arc	Düsseldorf	Nordrhein-Westfalen
Germany	Ruhrlandklinik Essen	Essen	Nordrhein-Westfalen
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	Universitätsklinikum SH	Lübeck	Schleswig-Holstein
Germany	Klinikum Nürnberg-Med Klinik 3	Nürnberg	Bavaria
Germany	University Hospital Regensburg	Regensburg	Bayern
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	Lisbon
Portugal	Hospital Sao Joao	Porto
Spain	Hospital de Cruces	Barakaldo
Spain	Hospital Clinic	Barcelona
Spain	Hospital General de Asturias	Oviedo
Switzerland	Inselspital	Bern
Switzerland	Centre d' investigation et de recherche sur le sommeil	Lausanne

Sponsors (3)

Lead Sponsor	Collaborator
ResMed	CRI-The Clinical Research Institute GmbH, University Hospital Regensburg

Countries where clinical trial is conducted

Denmark,  France,  Germany,  Portugal,  Spain,  Switzerland, 

References & Publications (1)

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. — View Citation

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 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
Primary	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	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).	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.	12 months
Secondary	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.	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 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.	6 months
Secondary	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).	6 months
Secondary	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).	6 months
Secondary	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.	6 months
Secondary	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.	Baseline to 12 months
Secondary	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).	Baseline to 12 months
Secondary	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.	Baseline to 12 months
Secondary	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.	12 months
Secondary	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.	12 months