Undiagnosed Sleep Apnea and Bypass OperaTion (SABOT)
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|ClinicalTrials.gov Identifier: NCT02701504|
Recruitment Status : Recruiting
First Posted : March 8, 2016
Last Update Posted : March 21, 2018
|Condition or disease|
The SABOT Study is an observational study designed to study the impact of sleep apnea on cardiovascular outcomes after non-urgent coronary artery bypass surgery (CABG). Patients between the ages of 18 and 90 who are scheduled undergo an non-urgent CABG were eligible for the study
Sleep Apnea Screening Questionnaire All recruited patients will be asked to complete the Berlin Questionnaire and Epworth Sleepiness Scale questionnaire. The Berlin Questionnaire is a validated screening tool used to identify individuals at high risk of sleep apnea. It consists of 10 items in three categories, assessing the presence and intensity of snoring, the severity of daytime somnolence, and the presence of hypertension and obesity. A positive score in two or more categories indicates a high risk of sleep apnea. The Epworth Sleepiness Scale is a validated questionnaire that identifies the perceived likelihood of falling asleep during eight everyday situations. Patients were asked to rate their likelihood of falling asleep during each scenario on a scale of 0-3, for a total score ranging from 0 to 24. Excessive daytime sleepiness was defined as an Epworth Sleepiness Scale score > 10.
Overnight Sleep Study The consenting participants were scheduled to undergo a hospital-based overnight sleep study using a US Food and Drug Administration-approved portable monitoring devices: the Watch-PAT (Itamar Medical, Caesarea, Israel). Watch-PAT is a four-channel unattended sleep monitoring device that measures peripheral arterial tone (PAT), pulse oximetry, heart rate, and actigraphy from a built-in actigraph. Respiratory events are identified by digital vasoconstriction mediated by α-adrenergic receptors that are sensitive to surges in sympathetic activity. Respiratory events are considered to be present when one of the following three criteria was met: a reduction in PAT amplitude with an acceleration of the pulse rate or an increase in wrist activity; a reduction in PAT amplitude with ≥3% oxyhemoglobin desaturation; and ≥4% oxyhemoglobin desaturation only. Although manual scoring and editing of the Watch-PAT signals are possible, we adopted results generated by the device algorithm alone with no intervention by the operator. The diagnosis of sleep apnea is confirmed if the AHI was greater than 15 events/h.
End Points The pre-specified primary end point is a major adverse cardiac and cerebrovascular event (MACCE), defined as a composite of cardiovascular mortality, non-fatal myocardial infarction, non-fatal stroke, and repeat revascularization. The secondary end point comprised sudden cardiac death or resuscitated cardiac arrest, all-cause mortality, and hospitalization for heart failure.
|Study Type :||Observational|
|Estimated Enrollment :||1000 participants|
|Official Title:||Association Between Sleep Apnea and Occurrence of Major Adverse Cardiovascular Events After Coronary Artery Bypass Grafting|
|Actual Study Start Date :||October 2013|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2019|
Sleep apnea group
The patients who are found to have sleep apnea based on the results of the portable sleep study
Non sleep apnea group
The patients who are found to have no sleep apnea based on the results of the portable sleep study
- Major Adverse Cardiac and Cerebrovascular Events [ Time Frame: Average of 2 years after CABG ]The number of patients with cardiac mortality, stroke, myocardial infarction, or repeat revascularization
- Other Cardiac and Cerebrovascular Events [ Time Frame: Average of 2 years after CABG ]Sudden cardiac death or resuscitated cardiac arrest, all-cause mortality, hospitalization for heart failure,
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02701504
|Contact: Venesa Loh||6772 firstname.lastname@example.org|
|National University Heart Centre, Singapore||Recruiting|
|Singapore, Singapore, 119228|
|Contact: Chi-Hang Lee, MD 67795555 ext 5597 email@example.com|
|Contact: Venesa Loh 67795555 ext 2166 firstname.lastname@example.org|
|Principal Investigator: Chieh-Yang Koo, MBBS|
|Study Chair:||Chi-Hang Lee, MD||National University, Singapore|