Validation of the ApneaScan Algorithm in Sleep Disordered Breathing (ApneaScan)

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.

Study Overview

• Status: Unknown
• Conditions: Heart Failure; Sleep-Disordered Breathing
• Intervention / Treatment: Device: Pacemaker/ICD

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 Type: Observational
• Enrollment (Anticipated): 180

Contacts and Locations

• Study Contact: Name: Simon G Pearse, MBChB; Phone Number: 2003 02073528121; Email: s.pearse@rbht.nhs.uk
• Study Contact Backup: Name: Ali Vazir, MBBS; Phone Number: 7716 02073528121; Email: a.vazir@imperial.ac.uk

Study Locations

• United Kingdom
  • London, United Kingdom, SW3 6NP
    • Recruiting
    • Royal Brompton and Harefield NHS Trust
    • Contact: Simon G Pearse, MBChB; Phone Number: 2003 02073528121; Email: s.pearse@rbht.nhs.uk
    • Contact: Ali Vazir, PhD; Phone Number: 2060 02073528121; Email: a.vazir@imperial.ac.uk
    • Sub-Investigator: Simon G Pearse, MBChB
    • Principal Investigator: Ali Vazir, PhD
    • Sub-Investigator: Martin Cowie, MD
    • Sub-Investigator: Michael Polkey, PhD
    • Sub-Investigator: Rakesh Sharma, PhD
    • Sub-Investigator: Tom Wong, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pacemaker/ICD with ApneaScan; Patients with HFREF due to receive a pacemaker or ICD with ApneaScan function	Device: Pacemaker/ICD; Implantation of an ICD or CRT device with ApneaScan function; Other Names: Invive, Inliven, Incepta, Energen, Autogen devices.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
B-Type Natriuretic peptide (BNP) concentration	BNP concentration correlated with severity of SDB	2 years
Ejection fraction on echocardiography	Correlation of ejection fraction and severity of SDB	2 years
6 minute walk test distance	Correlation between 6MWTd and severity of SDB	2 years

Collaborators and Investigators

• Sponsor: Royal Brompton & Harefield NHS Foundation Trust
• Collaborators: Boston Scientific Corporation
• Investigators: Principal Investigator: Ali Vazir, PhD, Royal Brompton & Harefield NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Anticipated): March 1, 2017
• Study Completion (Anticipated): October 1, 2017

Study Registration Dates

• First Submitted: April 11, 2014
• First Submitted That Met QC Criteria: July 28, 2014
• First Posted (Estimate): July 30, 2014

Study Record Updates

• Last Update Posted (Estimate): November 9, 2016
• Last Update Submitted That Met QC Criteria: November 8, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: Heart failure; Sleep-Disordered Breathing; Sleep Apnoea
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Heart Failure; Sleep Apnea Syndromes; Respiratory Aspiration
• Other Study ID Numbers: 14/LO/0077