Sleep ApneaSABOTNCT02701504
Undiagnosed Sleep Apnea and Bypass OperaTion
An observational study of Sleep Apnea, run by National University of Singapore at 1 site in Singapore.
Trial 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 after percutaneous coronary intervention. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Sleep Apnea
- How many people
- 1,000 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Oct 2013to 31 Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with coronary artery disease scheduled to undergo coronary artery bypass surgery
Who may be able to join
- Patients with coronary artery disease scheduled to undergo non-urgent coronary artery bypass surgery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Singapore1 site
National University Heart Centre, Singapore
Singapore, 119228
About this study
Official title: Association Between Sleep Apnea and Occurrence of Major Adverse Cardiovascular Events After Coronary Artery Bypass Grafting
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 after percutaneous coronary intervention. In the SABOT study, the investigators used a FDA-approved portable sleep device to diagnose sleep apnea, and evaluate the relationship between sleep apnea and cardiovascular outcomes after non-urgent coronary artery bypass surgery.
Read the 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
The recruited patients 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.
- Conditions
- Sleep Apnea
- Keywords
- sleep apnea, coronary artery bypass grafting, outcomes
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Cardiac and Cerebrovascular Events
The number of patients with cardiac mortality, stroke, myocardial infarction, or repeat revascularization
Measured: Average of 2 years after CABG
Secondary outcomes (1)
Other Cardiac and Cerebrovascular Events
Sudden cardiac death or resuscitated cardiac arrest, all-cause mortality, hospitalization for heart failure,
Measured: Average of 2 years after CABG
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2016 (estimated)
- Study start1 Oct 2013
- Primary completion31 Mar 2019
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Sleep ApneaStudies of the same condition, open and under way.
- More trials run by National University of SingaporeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chi-Hang Lee, National University of Singapore
- Investigators
- Chi-Hang Lee, MD, Study chair, National University of Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02701504
- Sponsor's protocol ID
- SABOT Study
- Acronym
- SABOT
- Status last verified
- Mar 2020
- First submitted
- 23 Sep 2014
- Last updated
- 26 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Teo YH, Yong CL, Ou YH, Tam WW, Teo YN, Koo CY, Kojodjojo P, Lee CH. Obstructive sleep apnea and temporal changes in cardiac repolarization in patients undergoing coronary artery bypass grafting. J Clin Sleep Med. 2024 Jan 1;20(1):49-55. doi: 10.5664/jcsm.10786.
PubMed 38163943Aung AT, Koo CY, Tam WW, Chen Z, Kristanto W, Sim HW, Kojodjojo P, Kofidis T, Lee CH. Sleep apnea and diabetes mellitus are independently associated with cardiovascular events and hospitalization for heart failure after coronary artery bypass grafting. Sci Rep. 2020 Dec 10;10(1):21664. doi: 10.1038/s41598-020-78700-9.
PubMed 33303900Koo CY, Aung AT, Chen Z, Kristanto W, Sim HW, Tam WW, Gochuico CF, Tan KA, Kang GS, Sorokin V, Ong PJL, Kojodjojo P, Richards AM, Tan HC, Kofidis T, Lee CH. Sleep apnoea and cardiovascular outcomes after coronary artery bypass grafting. Heart. 2020 Oct;106(19):1495-1502. doi: 10.1136/heartjnl-2019-316118. Epub 2020 May 18.
PubMed 32423904
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Sleep Apnea and Occurrence of Major Adverse Cardiovascular Events After Coronary Artery Bypass Grafting
- ClinicalTrials.gov ID
- NCT02701504
- Acronym / sponsor ID
- SABOT / SABOT Study
- Conditions
- Sleep Apnea
- Keywords
- sleep apnea, coronary artery bypass grafting, outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- National University of SingaporeUniversity, hospital or other
- Study start
- 1 Oct 2013 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 8 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 after percutaneous coronary intervention. In the SABOT study, the investigators used a FDA-approved portable sleep device to diagnose sleep apnea, and evaluate the relationship between sleep apnea and cardiovascular outcomes after non-urgent coronary artery bypass surgery.
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
The recruited patients 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with coronary artery disease scheduled to undergo coronary artery bypass surgery
Key inclusion criteria (1 listed)
- Patients with coronary artery disease scheduled to undergo non-urgent coronary artery bypass surgery
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Other Cardiac and Cerebrovascular Events
Time frame: Average of 2 years after CABG
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2020.
- Derived from this study: PubMed 38163943Teo YH, Yong CL, Ou YH, Tam WW, Teo YN, Koo CY, Kojodjojo P, Lee CH. Obstructive sleep apnea and temporal changes in cardiac repolarization in patients undergoing coronary artery bypass grafting. J Clin Sleep Med. 2024 Jan 1;20(1):49-55. doi: 10.5664/jcsm.10786.
- Derived from this study: PubMed 33303900Aung AT, Koo CY, Tam WW, Chen Z, Kristanto W, Sim HW, Kojodjojo P, Kofidis T, Lee CH. Sleep apnea and diabetes mellitus are independently associated with cardiovascular events and hospitalization for heart failure after coronary artery bypass grafting. Sci Rep. 2020 Dec 10;10(1):21664. doi: 10.1038/s41598-020-78700-9.
- Derived from this study: PubMed 32423904Koo CY, Aung AT, Chen Z, Kristanto W, Sim HW, Tam WW, Gochuico CF, Tan KA, Kang GS, Sorokin V, Ong PJL, Kojodjojo P, Richards AM, Tan HC, Kofidis T, Lee CH. Sleep apnoea and cardiovascular outcomes after coronary artery bypass grafting. Heart. 2020 Oct;106(19):1495-1502. doi: 10.1136/heartjnl-2019-316118. Epub 2020 May 18.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chi-Hang Lee, MD study chair
National University of Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Apnea, run by National University of Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Cardiac and Cerebrovascular Events (time frame: Average of 2 years after CABG). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02701504, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2020.