European Registry on the Treatment of Central and Complex Sleep-Disordered Breathing With Adaptive Servo-Ventilation (READ-ASV)

• ClinicalTrials.gov Identifier: NCT03032029
• Recruitment Status: Completed
• First Posted: January 26, 2017
• Last Update Posted: April 2, 2020
• Sponsor: ResMed
• Collaborators: The Clinical Research Institute Munich Germany; University Hospital Regensburg
• Information provided by (Responsible Party): ResMed

Study Description

Brief Summary:

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 1000 patients over a period of 5 years.

Condition or disease	Intervention/treatment
Central Sleep Apnea; Complex Sleep Apnea; Obstructive Sleep Apnea; Mixed Sleep Apnea	Device: Adaptive Servo-Ventilation

Detailed Description:

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.

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 200 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Target Follow-Up Duration: 12 Months
• Official Title: European Registry on the Treatment of Central and Complex Sleep-Disordered Breathing With Adaptive Servo-Ventilation
• Actual Study Start Date: September 5, 2017
• Actual Primary Completion Date: December 31, 2019
• Actual Study Completion Date: December 31, 2019

Groups and Cohorts

Intervention Details:

• Device: Adaptive Servo-Ventilation
  Bi-Level positive airway pressure with a targeted minute ventilation

Outcome Measures

Primary Outcome Measures :

1. Quality of Life, assessed with the Functional Outcomes of Sleep Questionnaire (FOSQ) by comparing the score at baseline with the 12 months follow-up. [ Time Frame: 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.

Secondary Outcome Measures :

1. Daytime symptoms assessed with the EuroQoL (EQ-5D) by comparing the answers at baseline with answers at the follow-up at 12 months. [ Time Frame: 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).
2. Daytime sleepiness assessed with the Epworth Sleepiness Scale (ESS) by comparing the score at baseline with the follow-up after 12 months. [ Time Frame: 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.
3. Quality of Sleep assessed with the Pittsburgh Sleep Quality Index (PSQI) at baseline compared with the follow-up after 12 months. [ Time Frame: 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.

4. Therapy compliance assessed by the hours of usage per night. [ Time Frame: 6 months ]
   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.
5. Apnea-Hypopnea-Index assessed by the number of Apneas and hypopneas per hour. [ Time Frame: 6 months ]
   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. Central Apnea Index assessed by the number of central apneas per hour. [ Time Frame: 6 months ]
   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).
7. Safety of ASV therapy assessed by documenting the number of adverse Events and the number of hospitalizations at the Overall end of the study. [ Time Frame: 6 months ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 99 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• 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.

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

Contacts and Locations

Locations

Germany

Schlaf- und Beatmungszentrum

Blaubeuren, Baden-Württemberg, Germany, 89143

Universitätsklinikum Heidelberg

Heidelberg, Baden-Württemberg, Germany, 69126

Klinik für Pneumologie, Schlaf- und Beatmungsmedizin

Kempten, Bayern, Germany, 87439

Klinikum Landshut

Landshut, Bayern, Germany, 84034

Lungenärzte am Rotkreuzplatz

München, Bayern, Germany, 86634

University Hospital Regensburg

Regensburg, Bayern, Germany, 93053

Medizinisches Zentrum

Bad Lippspringe, Nordrhein-Westfalen, Germany, 33175

Christophorus Kliniken

Dülmen, Nordrhein-Westfalen, Germany, 48249

Lungenklinik Hemer

Hemer, Nordrhein-Westfalen, Germany, 58675

Evangelisches Krankenhaus Herne

Herne, Nordrhein-Westfalen, Germany, 44623

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

Ibbenbüren, Nordrhein-Westfalen, Germany, 49477

Fachkrankenhaus Kloster Grafschaft

Schmallenberg, Nordrhein-Westfalen, Germany, 57392

Marienkrankenhaus Soest

Soest, Nordrhein-Westfalen, Germany, 59494

ZMS Zentrum für medizinische Studien

Warendorf, Nordrhein-Westfalen, Germany, 48231

Universitätsklinikum SH

Lübeck, Schleswig-Holstein, Germany, 23538

Sponsors and Collaborators

ResMed

The Clinical Research Institute Munich Germany

University Hospital Regensburg

More Information

Additional Information:

ResMed publication in pdf format 

• Responsible Party: ResMed
• ClinicalTrials.gov Identifier: NCT03032029
• Other Study ID Numbers: READ-ASV_Registry_Prot170404
• First Posted: January 26, 2017
• Last Update Posted: April 2, 2020
• Last Verified: March 2020

Additional relevant MeSH terms:

Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Sleep Apnea, Central; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases