Validation of the ApneaScan Algorithm in Sleep Disordered Breathing

Study Overview
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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.

Official Title
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Sleep-Disordered Breathing in Patients With Implanted Cardiac Devices: Validation of the ApneaScan Algorithm and Implications for Prognosis

Conditions
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Sleep-Disordered Breathing, Heart Failure

Intervention / Treatment
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* Device: Pacemaker/ICD


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pacemaker/ICD with ApneaScan<br>Patients with HFREF due to receive a pacemaker or ICD with ApneaScan function | Device: Pacemaker/ICD<br>* Implantation of an ICD or CRT device with ApneaScan function<br>* Other names: Invive, Inliven, Incepta, Energen, Autogen devices.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Apnoeic-Hypopnoeic Index (AHI) | We will compare that AHI from the ApneaScan pacemaker algorithm against the AHI from an Embletta sleep study. | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse heart failure events | Comprising hospital admissions for heart failure, AF burden, VF and VT burden and mortality | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sleep-Disordered Breathing, Sleep Apnoea, Heart failure