Validation of the "ApneaScan" Algorithm for the Detection of Sleep Disordered Breathing in Chronic Heart Failure
NCT ID: NCT01979120
Last Updated: 2013-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
200 participants
OBSERVATIONAL
2012-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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only 1 cohort!
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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Patient´s written informed consent
* Patients with a cardiac rhythm management device (ICD with or without cardiac resynchronization therapy function) of the "Incepta" series (including the ApneaScan algorithm) already implanted for at least 8 weeks (corresponding to the duration of the leads´ healing process); in order to standardize the enrollment period, inclusion should be effected between the first (the earliest 8 weeks after implantation) and the second routine control of ICD-function (the latest 9 months after implantation)
* Stable symptomatic chronic heart failure for either ischemic or non-ischemic reason (moderately to severely impaired systolic left ventricular function with NYHA-class II to III) under optimal pharmacological treatment (according to guidelines 2012 of the European Society of Cardiology)
Exclusion Criteria
* Patients already treated for sleep apnea syndrome (i.e. continuous positive airway pressure mask) or chronic obstructive pulmonary disease with GOLD-class IV (i.e. long-term oxygen therapy)
* A limited AHI detection by the ApneaScan algorithm until the planned inclusion (randomly defined by \<50% of countable AHI detection-points within the last 2 weeks).
* Patients with limited mobility due to orthopedic, neurologic or oncologic diseases (because of restricted assessment of exercise induced dyspnea)
* Patients on dialysis (either acute or chronic)
* Alcoholism or regular intake of hypnotics
* Pregnancy and lactation
18 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Dr. Christoph Schukro
OTHER
Responsible Party
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Dr. Christoph Schukro
Principle Investigator
Principal Investigators
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Christoph Schukro, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Medical University of Vienna
Locations
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Hietzing Hospital
Vienna, , Austria
Medical University of Vienna
Vienna, , Austria
SMZO
Vienna, , Austria
Wilhelminenspital
Vienna, , Austria
Wiener Neustadt Hospital
Wiener Neustadt, , Austria
Heart and Diabetes centre NRW
Bad Oeynhausen, , Germany
Klinikum Coburg
Coburg, , Germany
University of Leipzig
Leipzig, , Germany
Reinbek Hospital
Reinbek, , Germany
Kyushu University
Kyushu, , Japan
Tokyo Medical University
Tokyo, , Japan
Tottori University
Tottori, , Japan
Juntendo University School of Medicine
Urayasu, , Japan
University of Geneva
Geneva, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Christoph Schukro, MD, PhD
Role: primary
Other Identifiers
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ISROTH20033
Identifier Type: -
Identifier Source: org_study_id