Acronym | ISRCTN | EudraCT | NCT (clinicaltrials.gov) | DRKS |
---|---|---|---|---|
NCT03032029 |
Registry on the Treatment of Central and Complex Sleep-Disordered Breathing with Adaptive Servo-Ventilation / READ-ASV Registry A non-interventional, observational, prospective study
Status: Active (Recruitment Closed)
Changes in Functional Outcomes of Sleep Questionnaire (FOSQ) score comparing baseline with data at 12 ± 3 months of follow-up.
Changes in:
Daytime sleepiness, measured by Epworth Sleepiness Scale (ESS), comparing baseline with 12 ± 3 months of follow-up;
EuroQol five dimensions questionnaire (EQ-5D) score, comparing baseline with data at 12 ± 3 months of follow-up.
Relation of usage patterns of ASV therapy as measured by:
changes in ESS and EQ-5D scores and daytime symptoms between following usage patterns groups: usage per night ≥ 4 hours/< 4 hours and usage ≥ 70% of days; residual AHI of < 5/h, 5-15/h and > 15/h,
18-
≥ 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
Chronic, symptomatic heart failure (NYHA 2-4) with reduced left ventricular ejection fraction (LVEF ≤ 45%) and moderate to severe predominant central sleep apnea.
It is recommended in routine clinical care that subsequent clinical visits should be performed 1–2 times a year. Within this observational study at least one follow-up (FU) should be reported for each patient at 12 months (with a time frame of +/- 3 months in clinical routine) following enrolment.
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Active (Recruitment Closed)
Prof. Dr. Joachim H. Ficker