RESPIRE
Research type
Research Study
Full title
REgistry of Sleep Apnea monItoring and Atrial Fibrillation in pacemakeR patiEnts
IRAS ID
134905
Contact name
Simon Fynn
Contact email
Sponsor organisation
Sorin CRM SAS
Research summary
The object of the investigation relates to the function named Sleep Apnea Monitoring or SAM function,which is present in the REPLY 200 DR pacemakers, whose intended use is cardiac pacing.
SAS causes serious social and economic problems, not only because of its high prevalence but also because it is associated with increased cardiovascular morbidity and mortality.
Patients with Sleep Apnea often have high blood pressure,high risk of coronary artery disease and heart failure. A high percentage of these patients also show heart rhythm disturbances, particularly Atrial Fibrillation. These patients are also at increased risk of being involved in traffic accidents, as well as suffering a decline in their family, social, and professional lives. Therefore, the prompt diagnosis of these patients could be of great importance. The gold standard for diagnosis of SAS is overnight polysomnography (PSG) in a sleep laboratory. However, the shortage of sleep laboratories and the high cost of PSG render this method inadequate for widespread screening. In recent years, there have been attempts to develop an alternative diagnostic with a view to simplify the diagnosis.
SAM is included in REPLY 200 DR pacemakers, sequences of respiratory cycles are analyzed to detect, to count and to report abnormal breathing events during the night. This analysis is based on the Minute Ventilation (MV) signal. The MV signal represents the real time expansion/contraction of the thorax of the patient. The device is able to provide the physician with over 6 Months day-by-day Respiratory Disturbance Index (RDI) equal to the sum of events divided by the number of hours per night.
The purpose of the study is to evaluate at 12 Months the association between Atrial Fibrillation (AF) and Sleep Apnea (SA) severity based on data measured and stored in REPLY 200 DR pacemaker.REC name
South Central - Berkshire B Research Ethics Committee
REC reference
13/SC/0379
Date of REC Opinion
1 Jul 2013
REC opinion
Favourable Opinion