Obstructive Sleep ApneaSGMTNCT02599298
Sleep Study-Guided Multidisciplinary Therapy for Patients Presenting With Acute Coronary Syndrome
A study testing Continuous Positive Airway Therapy and Sleep-Study Guided Multidisciplinary Therapy in people with Obstructive Sleep Apnea and Acute Coronary Syndrome, run by National University of Singapore at 1 site in Singapore.
Trial summary
The aim of this randomized, open-label clinical trial is to determine the impact of Sleep Study-Guided Multidisciplinary Therapy (SGMT, i.e. continuous positive airway pressure and behavioral therapy) for obstructive sleep apnea (OSA) in the sub-acute phase of acute coronary syndrome on cardiovascular outcomes. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Obstructive Sleep Apnea, Acute Coronary Syndrome
- What is being tested?
- Continuous Positive Airway Therapy and Sleep-Study Guided Multidisciplinary Therapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 193 participants
- Where
- 1 siteSingapore
- Study dates
- 11 Jul 2016to Dec 2021
- Phase
- Interventional
- 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 21 years, admission with an acute coronary syndrome, competent informed consent, and the ability to follow all protocol procedures.
Who cannot join
- Known OSA being treated by CPAP, recommended coronary artery bypass surgery, concomitant moderate to severe structural valve disease, clinical instability (decompensated hypotension, heart failure, shock, refractory ventricular arrhythmias, acute conduction system disease, implanted defibrillator, or left ventricular ejection fraction ≤ 30%), limited life expectancy (< 1 year) due to a concomitant illness, prior or planned heart transplant or any other organ transplant, pregnancy or current nursing activity, or inability to give informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this randomized, open-label clinical trial is to determine the impact of Sleep Study-Guided Multidisciplinary Therapy (SGMT, i.e. continuous positive airway pressure and behavioral therapy) for obstructive sleep apnea (OSA) in the sub-acute phase of acute coronary syndrome on cardiovascular outcomes. We hypothesize that SGMT will result in a lower (1) plasma NT-pro BNP, ST2 levels and hs-CRP, (2) 10-year risk of cardiovascular mortality based on the European SCORE algorithm, and (3) cardiovascular event rate, when compared with Standard Therapy.
OSA is an emerging cardiac risk factor and prognostic marker. We have reported that OSA is a prevalent and independent predictor of adverse outcomes in patients with acute coronary syndrome. In this clinical trial, a continuation of my research and publication trajectory, 180 patients presenting with acute coronary syndrome will be randomly assigned to SGMT (n=90) or Standard Therapy (n=90) groups. Both groups will receive guideline-mandated treatment for acute coronary syndrome. Those assigned to SGMT will undergo a sleep study. Those found to have OSA will attend the SGMT clinic run by a multidisciplinary team. Advice on continuous positive airway pressure and behavioral therapy (weight loss, exercise, positional therapy, abstinence of alcohol and sleeping pills) will be given. The primary endpoint is plasma NT-pro BNP concentration at 6-month follow-up. The secondary endpoints are ST2, hs-CRP, 10-year risk of cardiovascular mortality based on the European SCORE algorithm which includes age, sex, smoking status, systolic blood pressure, and serum total cholesterol or total/HDL-cholesterol ratio. Adverse cardiovascular events at 3-year follow-up will be determined.
In our aging population with an increasing prevalence of obesity, OSA will potentially become an increasingly important contributor to cardiovascular disease. Leveraging the collective expertise of a team of cardiologists and sleep physicians, our work will benefit society by advancing our understanding of the cardiovascular benefits of screening for and treating OSA.
Read the detailed description
Acute coronary syndrome is a leading cause of mortality and morbidity globally. The Principal Investigator (PI) has been conducting research on sleep medicine and cardiovascular disease since 2007. Our early work has shown that obstructive sleep apnea (OSA) is prevalent in patients presenting with an acute coronary syndrome, and carries negative prognostic implications. This Clinician Scientist Award application is centered on the potential cardiovascular benefits of a Sleep Study-Guided Multidisciplinary Therapy (SGMT) that includes continuous positive airway pressure (CPAP) and behavioral therapy for patients presenting with an acute coronary syndrome, which could lead to a potential paradigm shift in patient management during the sub-acute phase of the syndrome. For this application, we have assembled a team of experts in cardiovascular medicine and sleep medicine. Using the leverage of the synergistic expertise of the assembled leaders and the knowledge generated in the early part of the program, we will embark on a therapeutic trial.
In this randomized trial, 180 patients presenting with an acute coronary syndrome will be recruited and randomized into SGMT versus standard therapy (without sleep study) groups. Both groups will be treated with a guideline-mandated therapy for acute coronary syndrome (including regular cardiology outpatient clinic visits after discharge). In those allocated to SGMT, an overnight sleep study using a level 3 portable diagnostic device will be carried out. Those with OSA (an estimated 75% according to the pilot data) will be treated with CPAP and behavioral therapy. Plasma N-terminal pro-brain natriuretic peptide (NT-proBNP), ST2, and hs-CRP levels will be measured before hospital discharge and at 6-month follow-up. The 10-year risk of cardiovascular mortality based on the European cardiovascular risk score (SCORE), which includes age, sex, smoking status, systolic blood pressure, and serum total cholesterol or total/high-density lipoprotein (HDL)-cholesterol ratio, will be determined at baseline and at 6-month follow-up.
Our specific aims are to compare the effects of SGMT and standard therapy on:
- Plasma levels of NT-proBNP (Primary endpoint), ST2 and hs-CRP. We hypothesize that SGMT will be associated with a lower plasma NT-proBNP, ST2 and hs-CRP levels than standard therapy at 6-month follow-up.
- Systematic COronary Risk Evaluation (SCORE). We hypothesize that SGMT will be associated with a lower SCORE than standard therapy at 6-month follow-up.
- Incidence of major adverse cardiac events (extended study). We hypothesize that SGMT will be associated with a lower incidence of major adverse cardiac events at 3-year follow-up (an application for additional funding will be made to accomplish this aim).
- Conditions
- Obstructive Sleep Apnea, Acute Coronary Syndrome
- Being tested
- Continuous Positive Airway Therapy, Sleep-Study Guided Multidisciplinary Therapy
- Keywords
- sleep, treatment
- Medical subject headings
- Sleep Apnea, Obstructive, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Positive Airway TherapyDevice
Also called CPAP
Sleep-Study Guided Multidisciplinary TherapyBehavioural
| Study group | Role | What they receive |
|---|---|---|
| SGMT arm | Active comparator | Treatment of OSA requires a multidisciplinary approach, involving a sleep physician and paramedical staff with expertise in the management of sleep disorders. An initial medical assessment is needed to confirm the diagnosis of OSA, determine its severity and decide whether CPAP therapy is appropriate. As part of this evaluation, an objective overnight sleep study will be performed. This will be followed by an assessment, education, and counseling at the multidisciplinary therapy clinic. Receives: Device: Continuous Positive Airway Therapy; Behavioral: Sleep-Study Guided Multidisciplinary Therapy |
| Control arm | No intervention | The patients will be treated according to the standard treatment for acute coronary syndrome in Singapore, which is largely in accordance with the recommendations of the American College of Cardiology and the American Heart Association. Management includes, but is not limited to, antiplatelet and lipid-lowering therapy, early coronary revascularization, and cardiac rehabilitation, with the recommendation to follow the current practice and the most recent international guidelines. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentration of NT-proBNP
Measured: 6-month
Secondary outcomes (4)
European cardiovascular risk SCORE
Measured: 6-month
Composite clinical endpoint of cardiovascular death, myocardial infarction (Q-wave and non-Q wave), stroke, unplanned revascularization, and hospitalization for heart failure
Measured: 12-month
Plasma concentration of ST2
Measured: 6-month
Plasma concentration of hs-CRP
Measured: 6-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2015 (estimated)
- Study start11 Jul 2016
- Primary completion20 Sep 2018
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 193 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02599298
- Sponsor's protocol ID
- NMRC CSA 2015
- Acronym
- SGMT
- Status last verified
- Oct 2020
- First submitted
- 4 Nov 2015
- Last updated
- 3 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Koo CY, Chua AP, Kristanto W, Koh EH, Tan ES, Abd Rahman S, Abd Gani MB, Chong JP, Aung AT, Han TO, Chan SP, Low AF, Yeo TC, Chan MY, Kojodjojo P, Richards AM, Lee CH. Screening and treatment of obstructive sleep apnea in acute coronary syndrome. A randomized clinical trial. Int J Cardiol. 2020 Jan 15;299:20-25. doi: 10.1016/j.ijcard.2019.07.003. Epub 2019 Jul 3.
PubMed 31307844
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Study-Guided Multidisciplinary Therapy for Patients Presenting With Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT02599298
- Acronym / sponsor ID
- SGMT / NMRC CSA 2015
- Conditions
- Obstructive Sleep Apnea, Acute Coronary Syndrome
- Keywords
- sleep, treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 193 participants (actual)
- Lead sponsor
- National University of SingaporeUniversity, hospital or other
- Study start
- 11 Jul 2016 (actual)
- Primary completion
- 20 Sep 2018 (actual)
- Study completion
- Dec 2021 (estimated)
- First posted
- 6 Nov 2015 (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.
The aim of this randomized, open-label clinical trial is to determine the impact of Sleep Study-Guided Multidisciplinary Therapy (SGMT, i.e. continuous positive airway pressure and behavioral therapy) for obstructive sleep apnea (OSA) in the sub-acute phase of acute coronary syndrome on cardiovascular outcomes. We hypothesize that SGMT will result in a lower (1) plasma NT-pro BNP, ST2 levels and hs-CRP, (2) 10-year risk of cardiovascular mortality based on the European SCORE algorithm, and (3) cardiovascular event rate, when compared with Standard Therapy.
OSA is an emerging cardiac risk factor and prognostic marker. We have reported that OSA is a prevalent and independent predictor of adverse outcomes in patients with acute coronary syndrome. In this clinical trial, a continuation of my research and publication trajectory, 180 patients presenting with acute coronary syndrome will be randomly assigned to SGMT (n=90) or Standard Therapy (n=90) groups. Both groups will receive guideline-mandated treatment for acute coronary syndrome. Those assigned to SGMT will undergo a sleep study. Those found to have OSA will attend the SGMT clinic run by a multidisciplinary team. Advice on continuous positive airway pressure and behavioral therapy (weight loss, exercise, positional therapy, abstinence of alcohol and sleeping pills) will be given. The primary endpoint is plasma NT-pro BNP concentration at 6-month follow-up. The secondary endpoints are ST2, hs-CRP, 10-year risk of cardiovascular mortality based on the European SCORE algorithm which includes age, sex, smoking status, systolic blood pressure, and serum total cholesterol or total/HDL-cholesterol ratio. Adverse cardiovascular events at 3-year follow-up will be determined.
In our aging population with an increasing prevalence of obesity, OSA will potentially become an increasingly important contributor to cardiovascular disease. Leveraging the collective expertise of a team of cardiologists and sleep physicians, our work will benefit society by advancing our understanding of the cardiovascular benefits of screening for and treating OSA.
Detailed description
Acute coronary syndrome is a leading cause of mortality and morbidity globally. The Principal Investigator (PI) has been conducting research on sleep medicine and cardiovascular disease since 2007. Our early work has shown that obstructive sleep apnea (OSA) is prevalent in patients presenting with an acute coronary syndrome, and carries negative prognostic implications. This Clinician Scientist Award application is centered on the potential cardiovascular benefits of a Sleep Study-Guided Multidisciplinary Therapy (SGMT) that includes continuous positive airway pressure (CPAP) and behavioral therapy for patients presenting with an acute coronary syndrome, which could lead to a potential paradigm shift in patient management during the sub-acute phase of the syndrome. For this application, we have assembled a team of experts in cardiovascular medicine and sleep medicine. Using the leverage of the synergistic expertise of the assembled leaders and the knowledge generated in the early part of the program, we will embark on a therapeutic trial.
In this randomized trial, 180 patients presenting with an acute coronary syndrome will be recruited and randomized into SGMT versus standard therapy (without sleep study) groups. Both groups will be treated with a guideline-mandated therapy for acute coronary syndrome (including regular cardiology outpatient clinic visits after discharge). In those allocated to SGMT, an overnight sleep study using a level 3 portable diagnostic device will be carried out. Those with OSA (an estimated 75% according to the pilot data) will be treated with CPAP and behavioral therapy. Plasma N-terminal pro-brain natriuretic peptide (NT-proBNP), ST2, and hs-CRP levels will be measured before hospital discharge and at 6-month follow-up. The 10-year risk of cardiovascular mortality based on the European cardiovascular risk score (SCORE), which includes age, sex, smoking status, systolic blood pressure, and serum total cholesterol or total/high-density lipoprotein (HDL)-cholesterol ratio, will be determined at baseline and at 6-month follow-up.
Our specific aims are to compare the effects of SGMT and standard therapy on:
- Plasma levels of NT-proBNP (Primary endpoint), ST2 and hs-CRP. We hypothesize that SGMT will be associated with a lower plasma NT-proBNP, ST2 and hs-CRP levels than standard therapy at 6-month follow-up.
- Systematic COronary Risk Evaluation (SCORE). We hypothesize that SGMT will be associated with a lower SCORE than standard therapy at 6-month follow-up.
- Incidence of major adverse cardiac events (extended study). We hypothesize that SGMT will be associated with a lower incidence of major adverse cardiac events at 3-year follow-up (an application for additional funding will be made to accomplish this aim).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SGMT arm | Active comparator | Device: Continuous Positive Airway Therapy, Behavioral: Sleep-Study Guided Multidisciplinary TherapyTreatment of OSA requires a multidisciplinary approach, involving a sleep physician and paramedical staff with expertise in the management of sleep disorders. An initial medical assessment is needed to confirm the diagnosis of OSA, determine its severity and decide whether CPAP therapy is appropriate. As part of this evaluation, an objective overnight sleep study will be performed. This will be followed by an assessment, education, and counseling at the multidisciplinary therapy clinic. |
| Control arm | No intervention | –The patients will be treated according to the standard treatment for acute coronary syndrome in Singapore, which is largely in accordance with the recommendations of the American College of Cardiology and the American Heart Association. Management includes, but is not limited to, antiplatelet and lipid-lowering therapy, early coronary revascularization, and cardiac rehabilitation, with the recommendation to follow the current practice and the most recent international guidelines. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age > 21 years, admission with an acute coronary syndrome, competent informed consent, and the ability to follow all protocol procedures.
Key exclusion criteria (1 listed)
- Known OSA being treated by CPAP, recommended coronary artery bypass surgery, concomitant moderate to severe structural valve disease, clinical instability (decompensated hypotension, heart failure, shock, refractory ventricular arrhythmias, acute conduction system disease, implanted defibrillator, or left ventricular ejection fraction ≤ 30%), limited life expectancy (< 1 year) due to a concomitant illness, prior or planned heart transplant or any other organ transplant, pregnancy or current nursing activity, or inability to give informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous Positive Airway TherapyAlso: CPAP | Device | SGMT arm |
| Sleep-Study Guided Multidisciplinary Therapy | Behavioural | SGMT arm |
Primary outcome
Plasma concentration of NT-proBNP
Time frame: 6-month
4 secondary outcomes
European cardiovascular risk SCORE
Time frame: 6-month
Composite clinical endpoint of cardiovascular death, myocardial infarction (Q-wave and non-Q wave), stroke, unplanned revascularization, and hospitalization for heart failure
Time frame: 12-month
Plasma concentration of ST2
Time frame: 6-month
Plasma concentration of hs-CRP
Time frame: 6-month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2020.
- Derived from this study: PubMed 31307844Koo CY, Chua AP, Kristanto W, Koh EH, Tan ES, Abd Rahman S, Abd Gani MB, Chong JP, Aung AT, Han TO, Chan SP, Low AF, Yeo TC, Chan MY, Kojodjojo P, Richards AM, Lee CH. Screening and treatment of obstructive sleep apnea in acute coronary syndrome. A randomized clinical trial. Int J Cardiol. 2020 Jan 15;299:20-25. doi: 10.1016/j.ijcard.2019.07.003. Epub 2019 Jul 3.
Related trials for Obstructive Sleep Apnea
RecruitingObservational study
Development and Clinical Validation of Artificial Intelligence Algorithms for Sleep Staging and Obstructive Sleep Apnea Screening Based on a Large-Scale Model Trained on Multimodal Physiological Signals From Diverse Populations
Sleep Apnea, Obstructive, Sleep Staging
RecruitingObservational study
Development of a Wearable Point of Care Monitoring Device for Pediatric Obstructive Sleep Apnea
Pediatric Obstructive Sleep Apnea
Not yet recruiting
Effect of High-flow Nasal Cannula Oxygenation on the Incidence of Hypoxemia During Painless Gastrointestinal Endoscopy in Patients at High Risk for Obstructive Sleep Apnea Syndrome in High-altitude Regions
Hypoxemia, Gastric Cancer (Diagnosis)
Not yet recruitingPhase 2
Oxytocin for Respiratory Compromise and Hypoventilation Induced by Drugs
Obesity & Overweight, Respiratory Depression
Enrolling by invitation
Myofunctional Therapy for Obstructive Sleep Apnea
Obstructive Sleep Apnea
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Positive Airway Therapy and Sleep-Study Guided Multidisciplinary Therapy in people with Obstructive Sleep Apnea and Acute Coronary Syndrome, 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 1 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: status not confirmed, as of the sponsor's last update on 3 Nov 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?
Results are not available in the source record.
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?
Plasma concentration of NT-proBNP (time frame: 6-month). 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 NCT02599298, which also lists 1 linked publication.
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 3 Nov 2020.