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Status unknownNCT01979120VASAUpdated Nov 8, 2013

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

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

The sponsor has not verified this record recently (last verified Aug 2013), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
18 Years and older
Sex
All
01

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.

02

Conditions studied

  • Sleep-disordered Breathing
  • Chronic Heart Failure

Keywords

  • Sleep-disordered breathing
  • Chronic heart failure
  • Implantable cardioverter-defibrillator
  • Apnea-Hypopnea-Index
  • Portable Polygraphy Monitoring
  • Polysomnography
03

In context

Respiratory Aspiration

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. Apnea-Hypopnea-Index

    Time frame: 1 night

Secondary outcomes

  1. Apnea-Hypopnea-Index >/= 30 (in-laboratory polysomnography)

    Time frame: 1 night

Other outcomes

  1. Mortality

    Time frame: 2 years

  2. Hospitalization

    Time frame: 2 years

  3. ICD therapies (i.e. shock or anti-tachycardia pacing)

    Time frame: 2 years

  4. atrial fibrillation

    Time frame: 2 years

  5. routine B-type natriuretic peptide

    only if applicable!

    Time frame: 1 night

07

Study locations

7 of 14 sites recruiting
  • Hietzing Hospital
    Vienna, Austria
    • Reinhard Achleitner, MD · Principal investigator
    Recruiting
  • Medical University of Vienna
    Vienna, Austria
    Recruiting
  • SMZO
    Vienna, Austria
    • Wolfgang Cozzarini, MD · Principal investigator
    Recruiting
  • Wilhelminenspital
    Vienna, Austria
    • Gabriele Jakl, MD · Principal investigator
    Recruiting
  • Wiener Neustadt Hospital
    Wiener Neustadt, Austria
    • Alexander Teubl, MD · Principal investigator
    Not yet recruiting
  • Heart and Diabetes centre NRW
    Bad Oeynhausen, Germany
    Active, not recruiting
  • Klinikum Coburg
    Coburg, Germany
    • Johannes Brachmann, MD · Principal investigator
    Recruiting
  • University of Leipzig
    Leipzig, Germany
    Active, not recruiting
  • Reinbek Hospital
    Reinbek, Germany
    • Herbert Nägele, MD · Principal investigator
    Recruiting
  • Kyushu University
    Kyushu, Japan
    • Shin-Ichi Ando, MD, PhD · Principal investigator
    Not yet recruiting
  • Tokyo Medical University
    Tokyo, Japan
    • Yoshifumi Takata, MD · Principal investigator
    Not yet recruiting
  • Tottori University
    Tottori, Japan
    • Masahiko Kato, MD, PhD · Principal investigator
    Not yet recruiting
  • Juntendo University School of Medicine
    Urayasu, Japan
    • Takatoshi Kasai, MD, PhD · Principal investigator
    Not yet recruiting
  • University of Geneva
    Geneva, Switzerland
    • Haran Burri, MD · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 8, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01979120
Lead sponsor
Dr. Christoph Schukro
Collaborators
Boston Scientific Corporation
Responsible party
Dr. Christoph Schukro (Principle Investigator, Medical University of Vienna) — Sponsor-investigator
First posted
Nov 8, 2013
Start date
Dec 2012
Primary completion
Aug 2014 (estimated)
Last update
Nov 8, 2013

Study contacts

Christoph Schukro, MD, PhD
Contact
christoph.schukro@meduniwien.ac.at
+43140400 ext. 4614
Christoph Schukro, MD, PhD
principal investigator · Medical University of Vienna

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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