Clinical trial NCT02204865: Validation of the ApneaScan Algorithm in Sleep Disordered Breathing
Official title: Sleep-Disordered Breathing in Patients With Implanted Cardiac Devices: Validation of the ApneaScan Algorithm and Implications for Prognosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sleep-Disordered Breathing
Heart Failure
Keywords: Sleep-Disordered Breathing
Sleep Apnoea
Heart failure
Lead sponsor: Royal Brompton & Harefield NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Boston Scientific Corporation
First posted: 2014-07-30
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with heart failure with reduced ejection fraction (EF \<40%) due to receive a Boston Scientific ICD/CRTD/P with ApneaScan function.

Brief 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. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The Apnoeic-Hypopnoeic Index (AHI)
timeFrame: 18 months
Secondary outcomes:
measure: Adverse heart failure events
timeFrame: 2 years
Other outcomes:
measure: B-Type Natriuretic peptide (BNP) concentration
timeFrame: 2 years
measure: Ejection fraction on echocardiography
timeFrame: 2 years
measure: 6 minute walk test distance
timeFrame: 2 years
Locations:
city: London
country: United Kingdom
facility: Royal Brompton and Harefield NHS Trust
Study officials:
affiliation: Royal Brompton & Harefield NHS Foundation Trust
name: Ali Vazir, PhD
role: PRINCIPAL_INVESTIGATOR
References: