Validation of the ApneaScan algorithm in sleep disordered breathing
Research type
Research Study
Full title
Sleep-Disordered Breathing in patients with implanted cardiac devices: Validation of the ApneaScan algorithm and implications for prognosis.
IRAS ID
136763
Contact name
Ali Vazir
Contact email
Sponsor organisation
Royal Brompton & Harefield NHS Trust
Research summary
Heart failure, where the output of blood from the heart is inadequate for the body’s requirements, is a common clinical problem with a poor prognosis despite advances in pharmacological, surgical and pacing therapy.
Around half of patients with heart failure suffer from sleep disordered breathing (SDB). There are 2 major types of SDB. Obstructive sleep apnoea (OSA) is a common clinical problem caused by loss of tone in the muscles of the throat during sleep, leading to snoring and apnoeas (cessation of breathing for >10 seconds). It is associated with obesity and predisposes to hypertension, heart disease and stroke. Central sleep apnoea (CSA) is a type of SDB in which breathing may be excessively deep for periods and then very shallow. The patient may stop breathing transiently. This pattern of breathing is associated with more severe heart failure and a poor prognosis.
We aim to validate whether a programme called ApneaScan, available on Boston Scientific pacemakers, which is designed to detect SDB is reliable. We will compare data collected from the pacemaker with data from sleep studies using an Embletta device (a portable sleep monitor).
Secondly, we will research whether there is a correlation between SDB, as detected by ApneaScan, and adverse outcomes over 2 years.
To achieve this we will recruit 72 patients who are to receive a pacemaker or defibrillator (which has the ability to treat abnormal heart rhythms). The patients will have their device checked 6-8 weeks following implantation alongside an Embletta sleep study to determine agreement between the two. We will also follow 180 patients with these pacemaker/defibrillators up over 2 years to document hospital admissions for heart failure, device therapies (i.e. special pacing algorithms or ’shocks’ for dangerous heart rhythms), atrial fibrillation burden and deaths to analyse whether ApneaScan data can predict prognosis.
REC name
London - Bromley Research Ethics Committee
REC reference
14/LO/0077
Date of REC Opinion
26 Feb 2014
REC opinion
Further Information Favourable Opinion