Validation of the ApneaScan Algorithm in Sleep Disordered... | NCT02204865

Studies
Validation of the ApneaScan Algorithm in Sleep Disordered Breathing

NCT02204865

Sponsor

Royal Brompton & Harefield NHS Foundation Trust

Status

Unknown status

Last Update Posted

Nov 9, 2016Estimated

Enrollment

180Estimated

Phase

Not provided

Conditions

Sleep-Disordered Breathing
Heart Failure

Interventions

Pacemaker/ICD

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2014

Primary Completion Date

Mar 2017Estimated

Completion Date

Oct 2017Estimated

First Submitted Date

Apr 11, 2014

First Submission Date that Met QC Criteria

Jul 28, 2014

First Posted Date

Jul 30, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 8, 2016

Last Update Posted Date

Nov 9, 2016Estimated

Name	Class
Boston Scientific Corporation	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

180Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pacemaker/ICD with ApneaScan		Patients with HFREF due to receive a pacemaker or ICD with ApneaScan function	Device: Pacemaker/ICD

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pacemaker/ICD	Device	Implantation of an ICD or CRT device with ApneaScan function	Pacemaker/ICD with ApneaScan

Outcomes Module

Primary Outcomes

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 Outcomes

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 Outcomes

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

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with heart failure with reduced ejection fraction (EF <40%) due to receive a Boston Scientific ICD/CRTD/P with ApneaScan function.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Simon G Pearse, MBChB	Contact	02073528121	2003	s.pearse@rbht.nhs.uk
Ali Vazir, MBBS	Contact	02073528121	7716	a.vazir@imperial.ac.uk

Overall Officials

Name	Affiliation	Role
Ali Vazir, PhD	Royal Brompton & Harefield NHS Foundation Trust	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Royal Brompton and Harefield NHS Trust	Recruiting	London	London	SW3 6NP	United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D012891	Sleep Apnea Syndromes
D006333	Heart Failure

Ancestor Terms

ID	Term
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D020919	Sleep Disorders, Intrinsic

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000098523	Device Lead Extraction

Ancestor Terms

ID	Term
D020878	Device Removal
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided