Validation of the ApneaScan Algorithm in Sleep Disordered Breathing
NCT02204865 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 180
Last updated 2016-11-09
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
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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