Sleep-disordered BreathingVASANCT01979120
Validation of the "ApneaScan" Algorithm for the Detection of Sleep Disordered Breathing in Chronic Heart Failure
An observational study of Sleep-disordered Breathing and Chronic Heart Failure, run by Dr. Christoph Schukro at 14 sites in 4 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep-disordered Breathing, Chronic Heart Failure
- How many people
- 200 participants
- Where
- 14 sitesin 4 countries
- Study dates
- Dec 2012to Aug 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with stable symptomatic chronic heart failure and implanted ICD/CRT-D of the "INCEPTA" series
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
14 sites in 4 countries.
14 sites in 4 countries
Austria5 sites, 5 recruiting
- Recruiting
Hietzing Hospital
Vienna
Reinhard Achleitner, MD
- Recruiting
Medical University of Vienna
Vienna
Christoph Schukro, MD, PhD, +43140400 ext. 4614, christoph.schukro@meduniwien.ac.at
Christoph Schukro, MD, PhD
- Recruiting
SMZO
Vienna
Wolfgang Cozzarini, MD
- Recruiting
Wilhelminenspital
Vienna
Gabriele Jakl, MD
- Not yet recruiting
Wiener Neustadt Hospital
Wiener Neustadt
Alexander Teubl, MD
Germany4 sites, 2 recruiting
- Active, not recruiting
Heart and Diabetes centre NRW
Bad Oeynhausen
- Recruiting
Klinikum Coburg
Coburg
Johannes Brachmann, MD
- Active, not recruiting
University of Leipzig
Leipzig
- Recruiting
Reinbek Hospital
Reinbek
Herbert Nägele, MD
Japan4 sites, 4 recruiting
- Not yet recruiting
Kyushu University
Kyushu
Shin-Ichi Ando, MD, PhD
- Not yet recruiting
Tokyo Medical University
Tokyo
Yoshifumi Takata, MD
- Not yet recruiting
Tottori University
Tottori
Masahiko Kato, MD, PhD
- Not yet recruiting
Juntendo University School of Medicine
Urayasu
Takatoshi Kasai, MD, PhD
Switzerland1 site, 1 recruiting
- Recruiting
University of Geneva
Geneva
Haran Burri, MD
About this study
Official title: Validation of the "ApneaScan" Algorithm for the Detection of Sleep Disordered Breathing in Patients With Stable Symptomatic Chronic Heart Failure
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
- Sleep-disordered Breathing, Chronic Heart Failure
- Keywords
- Sleep-disordered breathing, Chronic heart failure, Implantable cardioverter-defibrillator, Apnea-Hypopnea-Index, Portable Polygraphy Monitoring, Polysomnography
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea-Hypopnea-Index
Measured: 1 night
Secondary outcomes (1)
Apnea-Hypopnea-Index >/= 30 (in-laboratory polysomnography)
Measured: 1 night
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2013 (estimated)
- Study startDec 2012
- Primary completionAug 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep-disordered BreathingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Christoph Schukro
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Sponsor-investigator, Dr. Christoph Schukro, Medical University of Vienna
- Investigators
- Christoph Schukro, MD, PhD, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01979120
- Sponsor's protocol ID
- ISROTH20033
- Acronym
- VASA
- Status last verified
- Aug 2013
- First submitted
- 3 Nov 2013
- Last updated
- 8 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the "ApneaScan" Algorithm for the Detection of Sleep Disordered Breathing in Patients With Stable Symptomatic Chronic Heart Failure
- ClinicalTrials.gov ID
- NCT01979120
- Acronym / sponsor ID
- VASA / ISROTH20033
- Conditions
- Sleep-disordered Breathing, Chronic Heart Failure
- Keywords
- Sleep-disordered breathing, Chronic heart failure, Implantable cardioverter-defibrillator, Apnea-Hypopnea-Index, Portable Polygraphy Monitoring, Polysomnography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Dr. Christoph SchukroUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- Dec 2012
- Primary completion
- Aug 2014 (estimated)
- First posted
- 8 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with stable symptomatic chronic heart failure and implanted ICD/CRT-D of the "INCEPTA" series
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Apnea-Hypopnea-Index
Time frame: 1 night
1 secondary outcome
Apnea-Hypopnea-Index >/= 30 (in-laboratory polysomnography)
Time frame: 1 night
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christoph Schukro, MD, PhD principal investigator
Medical University of Vienna
14 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep-disordered Breathing and Chronic Heart Failure, run by Dr. Christoph Schukro at 14 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Austria, Germany, Japan, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christoph Schukro, MD, PhD (+43140400 ext. 4614, christoph.schukro@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apnea-Hypopnea-Index (time frame: 1 night). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2013.