NCT01979120

Brief 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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Geographic Reach
4 countries

14 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 3, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 8, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Last Updated

November 8, 2013

Status Verified

August 1, 2013

Enrollment Period

1.7 years

First QC Date

November 3, 2013

Last Update Submit

November 3, 2013

Conditions

Sleep-disordered BreathingChronic Heart Failure

Keywords

Sleep-disordered breathingChronic heart failureImplantable cardioverter-defibrillatorApnea-Hypopnea-IndexPortable Polygraphy MonitoringPolysomnography

Outcome Measures

Primary Outcomes (1)

  • Apnea-Hypopnea-Index

    1 night

Secondary Outcomes (1)

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

    1 night

Other Outcomes (5)

  • Mortality

    2 years

  • Hospitalization

    2 years

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

    2 years

  • +2 more other outcomes

Study Arms (1)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with stable symptomatic chronic heart failure and implanted ICD/CRT-D of the "INCEPTA" series

You may qualify if:

  • Age over 18 years
  • Patient´s written informed consent
  • 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)

You may not qualify if:

  • 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)
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Hietzing Hospital

Vienna, Austria

RECRUITING

Medical University of Vienna

Vienna, Austria

RECRUITING

SMZO

Vienna, Austria

RECRUITING

Wilhelminenspital

Vienna, Austria

RECRUITING

Wiener Neustadt Hospital

Wiener Neustadt, Austria

NOT YET RECRUITING

Heart and Diabetes centre NRW

Bad Oeynhausen, Germany

ACTIVE NOT RECRUITING

Klinikum Coburg

Coburg, Germany

RECRUITING

University of Leipzig

Leipzig, Germany

ACTIVE NOT RECRUITING

Reinbek Hospital

Reinbek, Germany

RECRUITING

Kyushu University

Kyushu, Japan

NOT YET RECRUITING

Tokyo Medical University

Tokyo, Japan

NOT YET RECRUITING

Tottori University

Tottori, Japan

NOT YET RECRUITING

Juntendo University School of Medicine

Urayasu, Japan

NOT YET RECRUITING

University of Geneva

Geneva, Switzerland

RECRUITING

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Christoph Schukro, MD, PhD

    Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christoph Schukro, MD, PhD

CONTACT

+43140400christoph.schukro@meduniwien.ac.at

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

November 3, 2013

First Posted

November 8, 2013

Study Start

December 1, 2012

Primary Completion

August 1, 2014

Last Updated

November 8, 2013

Record last verified: 2013-08

Locations

DE(4)JP(4)AU(5)CH(1)