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Trial record 18 of 391 for:    Recruiting, Not yet recruiting, Available Studies | "Sleep Apnea Syndromes"

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
Sponsor:
Information provided by (Responsible Party):
Chi-Hang Lee, National University, Singapore

Brief Summary:
Sleep apnea is a prevalent disorder in patients with coronary artery disease. Previous studies suggested sleep apnea was associated with coronary plaque burden and future adverse cardiovascular events. Sleep apnea is also associated with a high incidence of atrial fibrillation in patients undergoing coronary artery bypass grafting. Yet, previous reports used Berlin Questionnaire and Epworth Sleepiness Scale Questionnaire to diagnose sleep apnea. However, these screening questionnaires are not as accurate as a proper sleep study. In the SABOT study, the investigators used the portable sleep device to diagnose sleep apnea, and evaluate the relationship between sleep apnea and cardiovascular outcomes after coronary artery bypass surgery.

Condition or disease
Sleep Apnea

Detailed Description:

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
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort
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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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,



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients with coronary artery disease scheduled to undergo coronary artery bypass surgery
Criteria

Inclusion Criteria:

  • Patients with coronary artery disease scheduled to undergo non-urgent coronary artery bypass surgery

Exclusion Criteria:

  • Known sleep apnea on CPAP therapy
  • Cardiogenic shock on mechanical hemodynamic support
  • Intubated on mechanical ventilation
  • Heart failure on oxygen therapy
  • Long -term alpha blocker therapy
  • Severe chronic pulmonary disease
  • Recurrent malignant arrhythmia
  • Inability to provide informed consent

Information from the National Library of Medicine

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


Contacts
Contact: Venesa Loh 6772 2493 vlohjy@gmail.com

Locations
Singapore
National University Heart Centre, Singapore Recruiting
Singapore, Singapore, 119228
Contact: Chi-Hang Lee, MD    67795555 ext 5597    mdclchr@nus.edu.sg   
Contact: Venesa Loh    67795555 ext 2166    vlohjy@gmail.com   
Principal Investigator: Chieh-Yang Koo, MBBS         
Sponsors and Collaborators
National University, Singapore
Investigators
Study Chair: Chi-Hang Lee, MD National University, Singapore

Responsible Party: Chi-Hang Lee, Associate Professor, National University, Singapore
ClinicalTrials.gov Identifier: NCT02701504     History of Changes
Other Study ID Numbers: SABOT Study
First Posted: March 8, 2016    Key Record Dates
Last Update Posted: March 21, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Chi-Hang Lee, National University, Singapore:
sleep apnea
coronary artery bypass grafting
outcomes

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases