Heart FailureNCT02116686
ECG Derived Respiration for Automated Screening of Sleep Disordered Breathing in Chronic Heart Failure Patients
An observational study of Heart Failure and Sleep Apnea Syndromes, run by Centre Hospitalier Universitaire de Saint Etienne at 2 sites in France.
Trial summary
The prevalence of sleep disordered breathing (SDB) reaches more than 50% in chronic heart failure patients (CHF). The main consequence is an increase risk of fatal and non-fatal cardiovascular events. A treatment by continuous positive airway pressure (CPAP) or adaptative servo-ventilation (ASV) reduces this risk. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Sleep Apnea Syndromes, Polysomnography
- What is being tested?
- ventilatory polygraphic recordings
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 2 sitesFrance
- Study dates
- Jun 2013to Nov 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: Heart failure patients with sleep apnea syndrom
Who may be able to join
- chronic heart failure
- left ventricular ejection fraction < 45%
- New York Heart Association (NYHA) index ≥ 2
- Sleep apnea syndrom confirmed by polysomnography
Who cannot join
- Chronic Obstructive Pulmonary Disease with maximal Respiratory Volume < 50%
- Resting oxygen saturation < 90%
- Continuous Positive Airway Pressure (CPAP) or Adaptive Servo-Ventilation treatment
- Life expectancy < 1 year for other medical reasons than heart failure
- Cardiac surgery
- Percutaneous transluminal coronary angioplasty
Show all 13Show fewer
- Unstable angora during the 6 last months
- Implantation of a pacemaker or a defibrillator during the 6 last months
- Cerebrovascular accident or Transient Ischemic Attack during the 3 last months
- Restless legs syndrome
- Acute myocarditis or pericarditis during the 6 last months
- Valvular disease
- Pregnancy
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHU de Grenoble
Grenoble, 38000
CHU de Saint-Etienne
Saint-Etienne, 42000
About this study
The prevalence of sleep disordered breathing (SDB) reaches more than 50% in chronic heart failure patients (CHF). The main consequence is an increase risk of fatal and non-fatal cardiovascular events. A treatment by continuous positive airway pressure (CPAP) or adaptative servo-ventilation (ASV) reduces this risk. Nevertheless, 75% of severe SDB cases remains undiagnosed and untreated especially due to cost and time delay for polysomnography examination which is the gold standard for SDB diagnosis. Indeed, alternative methods are developed. Some methods, based on nocturnal ECG analysis showed promising results but they are not validated and adapted for cardiac population. Thus, the goal of present study is to test the accuracy of ECG derived respiration signal to screen SDB in a CHF population.
- Conditions
- Heart Failure, Sleep Apnea Syndromes, Polysomnography
- Being tested
- ventilatory polygraphic recordings
- Keywords
- chronic heart failure, Polysomnography, Sleep Apnea Syndromes, Electrocardiogram
- Medical subject headings
- Heart Failure, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ventilatory polygraphic recordingsDevice
Also called Embla device (Embla®, Broomfield, USA), RemLogic® software, Broomfield, USA
Standard nocturnal in-home ventilatory polygraphic recordings were performed using an Embla device (Embla®, Broomfield, USA) and scored according to the AASM recommendations (RemLogic® software, Broomfield, USA).
| Study group | Role | What they receive |
|---|---|---|
| Heart failure patients with sleep apnea syndrom | For heart failure patients, a standard nocturnal in-home ventilatory polygraphic recordings were performed using an Embla device (Embla®, Broomfield, USA) and scored according to the America Academy of Sleep Medicine (AASM) recommendations (RemLogic® software, Broomfield, USA). Receives: Device: ventilatory polygraphic recordings |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea Hypopnea Index (AHI)
Standard nocturnal in-home ventilatory polygraphic recordings. The AHI is calculated only on nocturnal ECG analysis
Measured: At patient polygraphic recording
Secondary outcomes (4)
AHI in subgroup patient with sinusal rhythm
Measured: At patient polygraphic recording
AHI in subgroup with implanted pacemaker
Measured: At patient polygraphic recording
AHI in subgroup with atrial fibrillation
Measured: At patient polygraphic recording
AHI in subgroup with bundle branch block
Measured: At patient polygraphic recording
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2014 (estimated)
- Study startJun 2013
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frederic ROCHE, MD PhD, Study director, CHU de Saint-Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02116686
- Sponsor's protocol ID
- OBS2014
- Status last verified
- Mar 2015
- First submitted
- 10 Apr 2014
- Last updated
- 31 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ECG Derived Respiration for Automated Screening of Sleep Disordered Breathing in Chronic Heart Failure Patients
- ClinicalTrials.gov ID
- NCT02116686
- Acronym / sponsor ID
- OBS2014
- Conditions
- Heart Failure, Sleep Apnea Syndromes, Polysomnography
- Keywords
- chronic heart failure, Polysomnography, Sleep Apnea Syndromes, Electrocardiogram
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 17 Apr 2014 (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.
The prevalence of sleep disordered breathing (SDB) reaches more than 50% in chronic heart failure patients (CHF). The main consequence is an increase risk of fatal and non-fatal cardiovascular events. A treatment by continuous positive airway pressure (CPAP) or adaptative servo-ventilation (ASV) reduces this risk. Nevertheless, 75% of severe SDB cases remains undiagnosed and untreated especially due to cost and time delay for polysomnography examination which is the gold standard for SDB diagnosis. Indeed, alternative methods are developed. Some methods, based on nocturnal ECG analysis showed promising results but they are not validated and adapted for cardiac population. Thus, the goal of present study is to test the accuracy of ECG derived respiration signal to screen SDB in a CHF population.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Heart failure patients with sleep apnea syndrom | – | Device: ventilatory polygraphic recordingsFor heart failure patients, a standard nocturnal in-home ventilatory polygraphic recordings were performed using an Embla device (Embla®, Broomfield, USA) and scored according to the America Academy of Sleep Medicine (AASM) recommendations (RemLogic® software, Broomfield, USA). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Heart failure patients with sleep apnea syndrom
Key inclusion criteria (4 listed)
- chronic heart failure
- left ventricular ejection fraction < 45%
- New York Heart Association (NYHA) index ≥ 2
- Sleep apnea syndrom confirmed by polysomnography
Key exclusion criteria (13 listed)
- Chronic Obstructive Pulmonary Disease with maximal Respiratory Volume < 50%
- Resting oxygen saturation < 90%
- Continuous Positive Airway Pressure (CPAP) or Adaptive Servo-Ventilation treatment
- Life expectancy < 1 year for other medical reasons than heart failure
- Cardiac surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ventilatory polygraphic recordingsAlso: Embla device (Embla®, Broomfield, USA), RemLogic® software, Broomfield, USAStandard nocturnal in-home ventilatory polygraphic recordings were performed using an Embla device (Embla®, Broomfield, USA) and scored according to the AASM recommendations (RemLogic® software, Broomfield, USA). | Device | Heart failure patients with sleep apnea syndrom |
Primary outcome
Apnea Hypopnea Index (AHI)
Time frame: At patient polygraphic recording
Standard nocturnal in-home ventilatory polygraphic recordings. The AHI is calculated only on nocturnal ECG analysis
4 secondary outcomes
AHI in subgroup patient with sinusal rhythm
Time frame: At patient polygraphic recording
AHI in subgroup with implanted pacemaker
Time frame: At patient polygraphic recording
AHI in subgroup with atrial fibrillation
Time frame: At patient polygraphic recording
AHI in subgroup with bundle branch block
Time frame: At patient polygraphic recording
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2015.
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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.
Frederic ROCHE, MD PhD study director
CHU de Saint-Etienne
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Sleep Apnea Syndromes, run by Centre Hospitalier Universitaire de Saint Etienne at 2 sites in France.
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 13 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: finished, as of the sponsor's last update on 31 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apnea Hypopnea Index (AHI) (time frame: At patient polygraphic recording). 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 31 Mar 2015.