Sleep-Disordered BreathingApneaScanNCT02204865
Validation of the ApneaScan Algorithm in Sleep Disordered Breathing
An observational study of Sleep-Disordered Breathing and Heart Failure, run by Royal Brompton & Harefield NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Sleep disordered breathing, in which patients my breath deeply, shallowly or stop breathing for periods whilst asleep, is common in heart failure and associated with a poor prognosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep-Disordered Breathing, Heart Failure
- What is being tested?
- Pacemaker/ICD
- Type of treatment
- Medical device
- How many people
- 180 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2014to Oct 2017
- 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 heart failure with reduced ejection fraction (EF <40%) due to receive a Boston Scientific ICD/CRTD/P with ApneaScan function.
Who may be able to join
- Heart failure with reduced ejection fraction (EF < 40%)
- Due to receive a device with ApneaScan function
- Able to give informed consent
- Ambulatory
Who cannot join
- Known sleep disordered breathing on Non-Invasive Ventilation therapy.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Brompton and Harefield NHS Trust
London, London, SW3 6NP
Simon G Pearse, MBChB, 02073528121 ext. 2003, s.pearse@rbht.nhs.uk
Ali Vazir, PhD, 02073528121 ext. 2060, a.vazir@imperial.ac.uk
About this study
Official title: Sleep-Disordered Breathing in Patients With Implanted Cardiac Devices: Validation of the ApneaScan Algorithm and Implications for Prognosis
Sleep disordered breathing, in which patients my breath deeply, shallowly or stop breathing for periods whilst asleep, is common in heart failure and associated with a poor prognosis. This study aims to validate a novel function available on certain pacemakers which is designed to detect this condition.The investigators hypothesize that ApneaScan can accurately detect moderate to severe sleep disordered breathing in patients with heart failure as compared against an Embletta sleep study. The investigators will also follow up our patients for 2 years to determine whether the severity of sleep disordered breathing as assessed by ApneaScan correlates with prognosis.
Read the detailed description
72 patients with heart failure with reduced ejection fraction (HFREF) who have been selected to receive an Implantable Cardioverter-Defibrillator (ICD) or Cardiac Resynchronization Therapy Pacemaker or Defibrillator (CRT-P/D) will undergo pre-implant assessment with an echocardiogram, B-type Natriuretic Peptide (BNP) level, 6 minute walk test, Minnesota living with heart failure and Epworth sleepiness questionnaires. The patients will then have the device implanted. 6 to 8 weeks later the patent will undergo an Embletta home sleep study and download of the ApneaScan data from the device. The mean Apnoea-Hypopnoea Index (AHI) from the ApneaScan download will be compared with that derived from the sleep study. The patients will also have a repeat 6 minute walk test, echocardiogram and BNP level.
2 years after device implantation, all patients will be followed up to document deaths, hospital admissions, Atrial Fibrillation (AF) burden and appropriate therapies from ICD devices.
- Conditions
- Sleep-Disordered Breathing, Heart Failure
- Being tested
- Pacemaker/ICD
- Keywords
- Sleep-Disordered Breathing, Sleep Apnoea, Heart failure
- Medical subject headings
- Sleep Apnea Syndromes, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pacemaker/ICDDevice
Also called Invive, Inliven, Incepta, Energen, Autogen devices.
Implantation of an ICD or CRT device with ApneaScan function
| Study group | Role | What they receive |
|---|---|---|
| Pacemaker/ICD with ApneaScan | Patients with HFREF due to receive a pacemaker or ICD with ApneaScan function Receives: Device: Pacemaker/ICD |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Apnoeic-Hypopnoeic Index (AHI)
We will compare that AHI from the ApneaScan pacemaker algorithm against the AHI from an Embletta sleep study.
Measured: 18 months
Secondary outcomes (1)
Adverse heart failure events
Comprising hospital admissions for heart failure, AF burden, VF and VT burden and mortality
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2014 (estimated)
- Study startMar 2014
- Primary completionMar 2017 (estimated)
- Study completionOct 2017 (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
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Sponsor
- Investigators
- Ali Vazir, PhD, Principal investigator, Royal Brompton & Harefield NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02204865
- Sponsor's protocol ID
- 14/LO/0077
- Acronym
- ApneaScan
- Status last verified
- Nov 2016
- First submitted
- 11 Apr 2014
- Last updated
- 9 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep-Disordered Breathing in Patients With Implanted Cardiac Devices: Validation of the ApneaScan Algorithm and Implications for Prognosis
- ClinicalTrials.gov ID
- NCT02204865
- Acronym / sponsor ID
- ApneaScan / 14/LO/0077
- Conditions
- Sleep-Disordered Breathing, Heart Failure
- Keywords
- Sleep-Disordered Breathing, Sleep Apnoea, Heart failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- Mar 2014
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 30 Jul 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.
Sleep disordered breathing, in which patients my breath deeply, shallowly or stop breathing for periods whilst asleep, is common in heart failure and associated with a poor prognosis. This study aims to validate a novel function available on certain pacemakers which is designed to detect this condition.The investigators hypothesize that ApneaScan can accurately detect moderate to severe sleep disordered breathing in patients with heart failure as compared against an Embletta sleep study. The investigators will also follow up our patients for 2 years to determine whether the severity of sleep disordered breathing as assessed by ApneaScan correlates with prognosis.
Detailed description
72 patients with heart failure with reduced ejection fraction (HFREF) who have been selected to receive an Implantable Cardioverter-Defibrillator (ICD) or Cardiac Resynchronization Therapy Pacemaker or Defibrillator (CRT-P/D) will undergo pre-implant assessment with an echocardiogram, B-type Natriuretic Peptide (BNP) level, 6 minute walk test, Minnesota living with heart failure and Epworth sleepiness questionnaires. The patients will then have the device implanted. 6 to 8 weeks later the patent will undergo an Embletta home sleep study and download of the ApneaScan data from the device. The mean Apnoea-Hypopnoea Index (AHI) from the ApneaScan download will be compared with that derived from the sleep study. The patients will also have a repeat 6 minute walk test, echocardiogram and BNP level.
2 years after device implantation, all patients will be followed up to document deaths, hospital admissions, Atrial Fibrillation (AF) burden and appropriate therapies from ICD devices.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pacemaker/ICD with ApneaScan | – | Device: Pacemaker/ICDPatients with HFREF due to receive a pacemaker or ICD with ApneaScan function |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with heart failure with reduced ejection fraction (EF <40%) due to receive a Boston Scientific ICD/CRTD/P with ApneaScan function.
Key inclusion criteria (4 listed)
- Heart failure with reduced ejection fraction (EF < 40%)
- Due to receive a device with ApneaScan function
- Able to give informed consent
- Ambulatory
Key exclusion criteria (1 listed)
- Known sleep disordered breathing on Non-Invasive Ventilation therapy.
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 |
|---|---|---|
| Pacemaker/ICDAlso: Invive, Inliven, Incepta, Energen, Autogen devices.Implantation of an ICD or CRT device with ApneaScan function | Device | Pacemaker/ICD with ApneaScan |
Primary outcome
The Apnoeic-Hypopnoeic Index (AHI)
Time frame: 18 months
We will compare that AHI from the ApneaScan pacemaker algorithm against the AHI from an Embletta sleep study.
1 secondary outcome
Adverse heart failure events
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2016.
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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.
Ali Vazir, PhD principal investigator
Royal Brompton & Harefield NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep-Disordered Breathing and Heart Failure, run by Royal Brompton & Harefield NHS Foundation Trust at 1 site in United Kingdom.
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 1 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 9 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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 Simon G Pearse, MBChB (02073528121 ext. 2003, s.pearse@rbht.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Apnoeic-Hypopnoeic Index (AHI) (time frame: 18 months). 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 9 Nov 2016.