Validation of the ApneaScan Algorithm in Sleep Disordered Breathing

Heart Failure Clinical Trial

— ApneaScan  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02204865
• Other study ID #: 14/LO/0077
• Status: Recruiting
• Phase: N/A
• First received: April 11, 2014
• Last updated: November 8, 2016
• Start date: March 2014
• Est. completion date: October 2017

Study information

• Verified date: November 2016
• Source: Royal Brompton & Harefield NHS Foundation Trust
• Contact: Simon G Pearse, MBChB
• Phone: 02073528121
• Email: s.pearse[@]rbht.nhs.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: October 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Heart Failure
• Respiratory Aspiration
• Sleep-Disordered Breathing

Intervention

Device:
• Pacemaker/ICD
Implantation of an ICD or CRT device with ApneaScan function

Locations

Country	Name	City	State
United Kingdom	Royal Brompton and Harefield NHS Trust	London

Sponsors (2)

Lead Sponsor	Collaborator
Royal Brompton & Harefield NHS Foundation Trust	Boston Scientific Corporation

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	B-Type Natriuretic peptide (BNP) concentration	BNP concentration correlated with severity of SDB	2 years	No
Other	Ejection fraction on echocardiography	Correlation of ejection fraction and severity of SDB	2 years	No
Other	6 minute walk test distance	Correlation between 6MWTd and severity of SDB	2 years	No
Primary	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	No
Secondary	Adverse heart failure events	Comprising hospital admissions for heart failure, AF burden, VF and VT burden and mortality	2 years	No