Validation of the ApneaScan Algorithm in Sleep Disordered Breathing

NCT02204865 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 180

Last updated 2016-11-09

No results posted yet for this study

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

Interventions

DEVICE

Pacemaker/ICD

Implantation of an ICD or CRT device with ApneaScan function

Sponsors & Collaborators

  • Boston Scientific Corporation

    collaborator INDUSTRY
  • Royal Brompton & Harefield NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Ali Vazir, PhD · Royal Brompton & Harefield NHS Foundation Trust

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2017-03-31
Completion
2017-10-31

Countries

  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02204865 on ClinicalTrials.gov