An observational study in Sleep-disordered Breathing and Chronic Heart Failure, sponsored by Dr. Christoph Schukro. Status unknown at 14 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-11-08.
Sponsored by Dr. Christoph Schukro · Observational
A prospective observational multi-centre study for the validation of the ApneaScan algorithm (integrated in ICD devices (with or without cardiac resynchronization therapy function) of the "Incepta" series for the screening of sleep disordered breathing in patients with stable symptomatic chronic heart failure, using portable polygraphy monitoring device ("Embletta Gold") as reference for the Apnea-Hypopnea-Index (AHI).
Secondary objectives are the detection of severe sleep disordered breathing in patients with clinically indicated in-laboratory polysomnography, as well as correlations of the AHI detected by ApneaScan with other clinical endpoints like mortality, hospitalization, atrial fibrillation and ventricular arrhythmia.
1,092 studies on the registry are indexed under Respiratory Aspiration; 216 are open to participants now.
This study's planned enrollment of 200 is above the median of 65 across 184 observational studies indexed under Respiratory Aspiration.
Browse Respiratory Aspiration studies →This is the only study on the registry with Dr. Christoph Schukro as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Patients with stable symptomatic chronic heart failure and implanted ICD/CRT-D of the "INCEPTA" series
Exclusion Criteria:
All patients already got an ICD implanted which includes an algorithm for screening of sleep-disordered breathing and will be examined by an portable polygraphy monitor in order to compare the Apnea-Hypopnea-Index.
Apnea-Hypopnea-Index
Time frame: 1 night
Apnea-Hypopnea-Index >/= 30 (in-laboratory polysomnography)
Time frame: 1 night
Mortality
Time frame: 2 years
Hospitalization
Time frame: 2 years
ICD therapies (i.e. shock or anti-tachycardia pacing)
Time frame: 2 years
atrial fibrillation
Time frame: 2 years
routine B-type natriuretic peptide
only if applicable!
Time frame: 1 night
This study is status unknown, as verified in Aug 2013. You cannot join it, but the record below documents what was studied.
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