- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03032029
Registry on the Treatment of Central and Complex Sleep-Disordered Breathing With Adaptive Servo-Ventilation (READ-ASV)
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Køge, Denmark
- Sjællands Universitetshospital/Zealand University Hospital Køge
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Odense, Denmark, 5000
- Odense Universitetshospital
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Grenoble, France, 38043
- Centre Hospitalier Universitaire Grenoble Alpes
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Baden-Württemberg
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Blaubeuren, Baden-Württemberg, Germany, 89143
- Schlaf- und Beatmungszentrum
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Heidelberg, Baden-Württemberg, Germany, 69126
- Universitätsklinikum Heidelberg
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Karlsruhe, Baden-Württemberg, Germany, 76133
- Klinikum Karlsruhe
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Bavaria
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Nürnberg, Bavaria, Germany, 90419
- Klinikum Nürnberg-Med Klinik 3
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Bayern
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Kempten, Bayern, Germany, 87439
- Klinik für Pneumologie, Schlaf- und Beatmungsmedizin
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Landshut, Bayern, Germany, 84034
- Klinikum Landshut
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Regensburg, Bayern, Germany, 93053
- University Hospital Regensburg
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Nordrhein-Westfalen
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Bad Lippspringe, Nordrhein-Westfalen, Germany, 33175
- Medizinisches Zentrum
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Bielefeld, Nordrhein-Westfalen, Germany, 33617
- Praxis für Lunge, Herz und Schlaf
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Dülmen, Nordrhein-Westfalen, Germany, 48249
- Christophorus Kliniken
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Düsseldorf, Nordrhein-Westfalen, Germany, 40235
- Klinik für Schlafmedizin Düsseldorf Grand Arc
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Essen, Nordrhein-Westfalen, Germany, 45239
- Ruhrlandklinik Essen
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Hemer, Nordrhein-Westfalen, Germany, 58675
- Lungenklinik Hemer
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Herne, Nordrhein-Westfalen, Germany, 44623
- Evangelisches Krankenhaus Herne
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Ibbenbüren, Nordrhein-Westfalen, Germany, 49477
- Praxis für Pneumologie, Allergologie, Schlafmedizin Dr. med Christoph Stolpe
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Schmallenberg, Nordrhein-Westfalen, Germany, 57392
- Fachkrankenhaus Kloster Grafschaft
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Soest, Nordrhein-Westfalen, Germany, 59494
- Marienkrankenhaus Soest
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Warendorf, Nordrhein-Westfalen, Germany, 48231
- ZMS Zentrum für medizinische Studien
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Schleswig-Holstein
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Lübeck, Schleswig-Holstein, Germany, 23538
- Universitätsklinikum SH
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Lisbon, Portugal
- Hospital de Santa Maria
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Porto, Portugal
- Hospital Sao Joao
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Barakaldo, Spain
- Hospital de Cruces
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Barcelona, Spain
- Hospital Clínic
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Oviedo, Spain
- Hospital General De Asturias
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Bern, Switzerland, 3010
- Inselspital
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Lausanne, Switzerland, 1011
- Centre d' investigation et de recherche sur le sommeil
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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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
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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.
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12 months
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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.
Time Frame: Baseline to 12 months
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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).
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Baseline to 12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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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
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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).
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12 months
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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
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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.
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12 months
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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
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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
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Therapy compliance assessed by the hours of usage per night.
Time Frame: 6 months
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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.
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6 months
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Apnea-Hypopnea-Index assessed by the number of Apneas and hypopneas per hour.
Time Frame: 6 months
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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).
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6 months
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Central Apnea Index assessed by the number of central apneas per hour.
Time Frame: 6 months
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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).
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6 months
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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
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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.
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6 months
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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.
Time Frame: Baseline to 12 months
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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.
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Baseline to 12 months
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Phase 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: Baseline to 12 months
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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).
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Baseline to 12 months
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Phase 2: Therapy compliance assessed by the hours of usage per night.
Time Frame: Baseline to 12 months
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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.
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Baseline to 12 months
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Phase 2: Rate of hospitalizations for cardiovascular or respiratory cause per year of follow-up.
Time Frame: 12 months
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All unplanned hospitalizations will be recorded as serious adverse events and assessed for cause of hospitalisation: cardiovascular or respiratory cause.
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12 months
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Phase 2: Rate of all-cause deaths per year of follow-up.
Time Frame: 12 months
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All deaths will be recorded.
Cause of death will be assessed through the documentation in the study centers.
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12 months
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Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- READ-ASV_Reg_Protoc_170404
- Protocol 2019-04-16 (Other Identifier: ResMed)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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