AP Scan Validation Study
Research type
Research Study
Full title
Validation of an automated algorithm in cardiac implantable electronic devices for the diagnosis of advanced sleep disordered breathing in heart failure
IRAS ID
166269
Contact name
Dennis W.S. Chong
Contact email
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Sleep disordered breathing (SDB) encompasses obstructive sleep apnoea and central sleep apnoea. It often co-exists in patients with heart failure, with an estimated prevalence of 50%. Implantable electronic cardiac devices such as pacemakers and implantable cardioverter-defibrillators (ICD) have demonstrated potential for diagnosing SDB. They utilise sensors that measure the changes in chest wall impedance during breathing and apply an automated algorithm to derive a measurement of sleep disturbance episodes. Its use in the "real world" is limited due to lack of clinician confidence as it has not been validated outside the sleep laboratory setting.
The proposed study will focus on heart failure patients with an ICD or cardiac resynchronisation therapy (CRT) device. We seek to validate the diagnostic accuracy of the automated algorithm APScan (Boston Scientific, Minnesota, USA) for the detection of advanced sleep disordered breathing by comparison to a portable sleep study monitor (NOX T3, Resmed) in the real world setting.
We aim to recruit 50 patients with heart failure and an ICD or CRT device with the APScan algorithm from the device follow up clinics. Patients will be recruited from two sites, Liverpool Heart and Chest Hospital and Nobles Hospital, Isle of Man. Patients will undergo an overnight sleep study with a portable monitor in their own home. An apnoea/hypopnoea index will be derived and compared to an index measured by the APScan algorithm on their cardiac device on the same night, as well as a one-month nightly average reading.
We will correlate patients diagnosed with SDB with their symptoms using the NYHA class and Epworth Sleepiness Score and patient related outcome measures, including hospitalisation, ICD therapy, and mortality.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
15/NW/0106
Date of REC Opinion
2 Apr 2015
REC opinion
Further Information Favourable Opinion