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Validation of the ApneaScan Algorithm in Sleep Disordered Breathing

NCT ID: NCT02204865

Last Updated: 2016-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

180 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-03-31

Study Completion Date

2017-10-31

Brief Summary

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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

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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

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Sleep-Disordered Breathing Heart Failure

Keywords

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Sleep-Disordered Breathing Sleep Apnoea Heart failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Pacemaker/ICD with ApneaScan

Patients with HFREF due to receive a pacemaker or ICD with ApneaScan function

Pacemaker/ICD

Intervention Type DEVICE

Implantation of an ICD or CRT device with ApneaScan function

Interventions

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Pacemaker/ICD

Implantation of an ICD or CRT device with ApneaScan function

Intervention Type DEVICE

Other Intervention Names

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Invive, Inliven, Incepta, Energen, Autogen devices.

Eligibility Criteria

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Inclusion Criteria

* Heart failure with reduced ejection fraction (EF \< 40%)
* Due to receive a device with ApneaScan function
* Able to give informed consent
* Ambulatory

Exclusion Criteria

* Known sleep disordered breathing on Non-Invasive Ventilation therapy.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston Scientific Corporation

INDUSTRY

Sponsor Role collaborator

Royal Brompton & Harefield NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ali Vazir, PhD

Role: PRINCIPAL_INVESTIGATOR

Royal Brompton & Harefield NHS Foundation Trust

Locations

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Royal Brompton and Harefield NHS Trust

London, London, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Simon G Pearse, MBChB

Role: CONTACT

Phone: 02073528121

Email: [email protected]

Ali Vazir, MBBS

Role: CONTACT

Phone: 02073528121

Email: [email protected]

Facility Contacts

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Simon G Pearse, MBChB

Role: primary

Ali Vazir, PhD

Role: backup

Other Identifiers

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14/LO/0077

Identifier Type: -

Identifier Source: org_study_id