Validation of the ApneaScan Algorithm in Sleep Disordered Breathing

NCT02204865 | Unknown DMC

• 1 other identifier: 14/LO/0077
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep-Disordered Breathing; Heart Failure

Keywords

Sleep-Disordered Breathing; Sleep Apnoea; Heart failure

Outcome Measures

Primary Outcomes (1)

• 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 (1)

• Adverse heart failure events

  2 years

Other Outcomes (3)

• B-Type Natriuretic peptide (BNP) concentration

  2 years

• Ejection fraction on echocardiography

  2 years

• 6 minute walk test distance

  2 years

Study Arms (1)

Pacemaker/ICD with ApneaScan

Patients with HFREF due to receive a pacemaker or ICD with ApneaScan function

Device: Pacemaker/ICD

Interventions

Pacemaker/ICD DEVICE

Implantation of an ICD or CRT device with ApneaScan function

Also known as: Invive, Inliven, Incepta, Energen, Autogen devices.

Pacemaker/ICD with ApneaScan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Heart failure with reduced ejection fraction (EF \< 40%)
• Due to receive a device with ApneaScan function
• Able to give informed consent
• Ambulatory

You may not qualify if:

• Known sleep disordered breathing on Non-Invasive Ventilation therapy.

Sponsors & Collaborators

• Royal Brompton & Harefield NHS Foundation Trust: lead
• Boston Scientific Corporation: collaborator

Study Sites (1)

Royal Brompton and Harefield NHS Trust

London, London, SW3 6NP, United Kingdom

RECRUITING

MeSH Terms

Conditions

Sleep Apnea Syndromes; Heart Failure

Interventions

Device Lead Extraction

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Device Removal; Surgical Procedures, Operative

Study Officials

• Ali Vazir, PhD

  Royal Brompton & Harefield NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Simon G Pearse, MBChB

CONTACT

02073528121; s.pearse@rbht.nhs.uk

Ali Vazir, MBBS

CONTACT

02073528121; a.vazir@imperial.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2014
• First Posted: July 30, 2014
• Study Start: March 1, 2014
• Primary Completion: March 1, 2017
• Study Completion: October 1, 2017
• Last Updated: November 9, 2016

Record last verified: 2016-11

Locations

GB (1)