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Validation of the "ApneaScan" Algorithm for the Detection of Sleep Disordered Breathing in Chronic Heart Failure

NCT01979120 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2013-11-08

No results posted yet for this study

Summary

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.

Conditions

Sponsors & Collaborators

  • Boston Scientific Corporation

    collaborator INDUSTRY

  • Dr. Christoph Schukro

    lead OTHER

Principal Investigators

  • Christoph Schukro, MD, PhD · Medical University of Vienna

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2014-08-31

Countries

  • Austria
  • Germany
  • Japan
  • Switzerland

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01979120 on ClinicalTrials.gov