Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2013 by Medical University of Vienna.
Recruitment status was:  Recruiting
Boston Scientific Corporation
Information provided by (Responsible Party):
Dr. Christoph Schukro, Medical University of Vienna Identifier:
First received: November 3, 2013
Last updated: NA
Last verified: August 2013
History: No changes posted

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.

Sleep-disordered Breathing
Chronic Heart Failure

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Validation of the "ApneaScan" Algorithm for the Detection of Sleep Disordered Breathing in Patients With Stable Symptomatic Chronic Heart Failure

Resource links provided by NLM:

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Apnea-Hypopnea-Index [ Time Frame: 1 night ]

Secondary Outcome Measures:
  • Apnea-Hypopnea-Index >/= 30 (in-laboratory polysomnography) [ Time Frame: 1 night ]

Other Outcome Measures:
  • 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 [ Time Frame: 1 night ]
    only if applicable!

Estimated Enrollment: 200
Study Start Date: December 2012
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with stable symptomatic chronic heart failure and implanted ICD/CRT-D of the "INCEPTA" series

Inclusion Criteria:

  • Age over 18 years
  • 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:

  • Unstable heart failure (NYHA-class IV) or asymptomatic chronic heart failure (including patients with very mild exercise induced dyspnea, i.e. NYHA-class I)
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01979120

Contact: Christoph Schukro, MD, PhD +43140400 ext 4614

Hietzing Hospital Recruiting
Vienna, Austria
Principal Investigator: Reinhard Achleitner, MD         
Medical University of Vienna Recruiting
Vienna, Austria
Contact: Christoph Schukro, MD, PhD    +43140400 ext 4614   
Principal Investigator: Christoph Schukro, MD, PhD         
SMZO Recruiting
Vienna, Austria
Principal Investigator: Wolfgang Cozzarini, MD         
Wilhelminenspital Recruiting
Vienna, Austria
Principal Investigator: Gabriele Jakl, MD         
Wiener Neustadt Hospital Not yet recruiting
Wiener Neustadt, Austria
Principal Investigator: Alexander Teubl, MD         
Heart and Diabetes centre NRW Active, not recruiting
Bad Oeynhausen, Germany
Klinikum Coburg Recruiting
Coburg, Germany
Principal Investigator: Johannes Brachmann, MD         
University of Leipzig Active, not recruiting
Leipzig, Germany
Reinbek Hospital Recruiting
Reinbek, Germany
Principal Investigator: Herbert Nägele, MD         
Kyushu University Not yet recruiting
Kyushu, Japan
Principal Investigator: Shin-Ichi Ando, MD, PhD         
Tokyo Medical University Not yet recruiting
Tokyo, Japan
Principal Investigator: Yoshifumi Takata, MD         
Tottori University Not yet recruiting
Tottori, Japan
Principal Investigator: Masahiko Kato, MD, PhD         
Juntendo University School of Medicine Not yet recruiting
Urayasu, Japan
Principal Investigator: Takatoshi Kasai, MD, PhD         
University of Geneva Recruiting
Geneva, Switzerland
Principal Investigator: Haran Burri, MD         
Sponsors and Collaborators
Dr. Christoph Schukro
Boston Scientific Corporation
Principal Investigator: Christoph Schukro, MD, PhD Medical University of Vienna
  More Information

Responsible Party: Dr. Christoph Schukro, Principle Investigator, Medical University of Vienna Identifier: NCT01979120     History of Changes
Other Study ID Numbers: ISROTH20033
Study First Received: November 3, 2013
Last Updated: November 3, 2013

Keywords provided by Medical University of Vienna:
Sleep-disordered breathing
Chronic heart failure
Implantable cardioverter-defibrillator
Portable Polygraphy Monitoring

Additional relevant MeSH terms:
Heart Failure
Respiratory Aspiration
Heart Diseases
Cardiovascular Diseases
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes processed this record on May 22, 2017