European Registry on the Treatment of Central and Complex Sleep-Disordered Breathing With Adaptive Servo-Ventilation (READ-ASV)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03032029|
Recruitment Status : Completed
First Posted : January 26, 2017
Last Update Posted : April 2, 2020
|Condition or disease||Intervention/treatment|
|Central Sleep Apnea Complex Sleep Apnea Obstructive Sleep Apnea Mixed Sleep Apnea||Device: Adaptive Servo-Ventilation|
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||200 participants|
|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|
- Device: Adaptive Servo-Ventilation
Bi-Level positive airway pressure with a targeted minute ventilation
- 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.
- 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).
- 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.
- 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.
- 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.
- 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).
- 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).
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03032029
|Schlaf- und Beatmungszentrum|
|Blaubeuren, Baden-Württemberg, Germany, 89143|
|Heidelberg, Baden-Württemberg, Germany, 69126|
|Klinik für Pneumologie, Schlaf- und Beatmungsmedizin|
|Kempten, Bayern, Germany, 87439|
|Landshut, Bayern, Germany, 84034|
|Lungenärzte am Rotkreuzplatz|
|München, Bayern, Germany, 86634|
|University Hospital Regensburg|
|Regensburg, Bayern, Germany, 93053|
|Bad Lippspringe, Nordrhein-Westfalen, Germany, 33175|
|Dülmen, Nordrhein-Westfalen, Germany, 48249|
|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|
|Soest, Nordrhein-Westfalen, Germany, 59494|
|ZMS Zentrum für medizinische Studien|
|Warendorf, Nordrhein-Westfalen, Germany, 48231|
|Lübeck, Schleswig-Holstein, Germany, 23538|