Heart FailureMARVEL-HFNCT07460505
Mandibular Advancement to Reduce Ventricular Load and Improve Quality-of-life in Heart Failure
A study testing Mandibular advancement device in people with Heart Failure and OSA - Obstructive Sleep Apnea, run by National University Hospital, Singapore at 1 site in Singapore.
Trial summary
Heart failure with reduced ejection fraction (HFrEF) is a serious condition that limits daily activities and often leads to hospital stays and early death. Many patients with HFrEF also have obstructive sleep apnea (OSA), a common but often undiagnosed condition where breathing repeatedly stops during sleep. Read more about this study
- Who is it for?
- Ages 40 to 99 years
- Conditions the study is for
- Heart Failure, OSA - Obstructive Sleep Apnea
- What is being tested?
- Mandibular advancement device
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 328 participants
- Where
- 1 siteSingapore
- Study dates
- 1 May 2026to 1 Apr 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age of at least 40 years old with the capacity to provide signed, written informed consent
- Ischemic or non-ischemic cardiomyopathy with a left ventricular ejection fraction of 20% to 40% in the previous 6 months
- Stable chronic HF with NYHA functional class I-III symptoms on maximally tolerated background therapy for at least 4 weeks
- NT-proBNP >600 pg/mL (for participants in sinus rhythm) or >900 pg/mL (for participants in atrial fibrillation) in the previous 6 months (same as leading HF trials)
- Agree to follow the study protocol
- Able and willing to undergo a hospital-based overnight polysomnography
Who cannot join
- Known OSA and already on regular treatment
- Moderate or severe valvular stenosis or regurgitation
- Severe hypoxemia on polysomnography ODI >60 or min SpO2 <60%
- Specific HF etiologies, including hypertrophic cardiomyopathy with left ventricular outflow tract obstruction; pericardial disease; infiltrative or inflammatory myocardial disease; valvular heart disease with severe aortic or primary mitral regurgitation, moderate or severe aortic stenosis, any mitral stenosis requiring surgical repair, or active endocarditis
- Contraindications to MAD: less than six teeth in each arch; inability to advance the mandible and open the jaw widely.
- Pre-existing temporomandibular joint problems, severe bruxism, and advanced periodontal disease (with mobility affecting MAD stability).
Show all 10Show fewer
- Patients who are planning to have restorations, dental prostheses or implants done in the next 12 months
- Limited life expectancy (< one year)
- Cardiac or cerebrovascular events in the past 6 months, including myocardial infarction, unstable angina leading to hospitalization, uncontrolled cardiac arrhythmia, carotid surgery or stenting, stroke, transient ischemic attack, carotid revascularization, endovascular procedure, or surgical intervention for peripheral vascular disease
- Current or planned mechanical circulatory support or heart transplantation Current or planned (within the next 6 months) hemodialysis or peritoneal dialysis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore1 site
National University Hospital
Singapore, Kent Ridge, 119228
Chi-Hang Ronald Lee, MD, 91263120, mdclchr@nus.edu.sg
Juliana Colpani, BDS
About this study
Official title: Mandibular Advancement to Reduce Ventricular Load and Improve Quality of Life in Heart Failure - a Randomized Controlled Trial
Heart failure with reduced ejection fraction (HFrEF) is a serious condition that limits daily activities and often leads to hospital stays and early death. Many patients with HFrEF also have obstructive sleep apnea (OSA), a common but often undiagnosed condition where breathing repeatedly stops during sleep. This causes drops in oxygen, poor sleep, and stress on the heart, which can make heart failure worse.
The investigators are studying whether a device called a mandibular advancement device (MAD)-a mouthpiece worn during sleep that keeps the airway open-can help people with both HFrEF and moderate-to-severe OSA. This device is already approved to treat OSA and is often more comfortable and easier to use than a CPAP machine.
Read more
In our study, 328 patients in Singapore will be randomly assigned to use either the MAD or a sham device that looks the same but doesn't move the jaw. They will wear the device for 12 months. We will measure changes in a blood marker linked to heart failure severity, as well as exercise ability, blood pressure, sleep quality, and hospital visits.
The investigators hope this study will show that MAD is a simple and patient-friendly way to improve outcomes in people with heart failure.
Read the detailed description
Heart failure profoundly impacts health, quality-of-life, and survival. Patients with heart failure (HF) experience fatigue, breathlessness, and exercise intolerance. Recurrent hospitalizations due to disease exacerbations further burden patients and healthcare systems. Despite advances in therapies, long-term outcomes remain poor with only 50% survival at 5 years post-diagnosis. Based on the left ventricular ejection fraction, HF is classified into three categories: reduced, mildly reduced, and preserved ejection fraction. This proposal focuses specifically on HF with reduced ejection fraction, which carries the worst prognosis. The term "HF" in this proposal refers exclusively to this subtype.
A growing body of evidence highlights the critical role of non-traditional and modifiable risk factors in heart failure progression, with obstructive sleep apnea (OSA) emerging as a particularly important contributor. OSA is highly prevalent in patients with HF, with estimates ranging from 40% to 70%. However, it remains substantially underdiagnosed and undertreated. OSA is characterized by repeated collapse of the upper airway during sleep, resulting in intermittent hypoxia, hypercapnia, serial arousals, and surges in sympathetic activity and blood pressure. These stressors contribute to elevated cardiac afterload, myocardial oxygen demand, and neurohormonal activation-all of which exacerbate ventricular dysfunction and HF progression. The relationship between OSA and HF is bidirectional. OSA not only contributes to the worsening of HF, but HF itself can increase the likelihood of OSA due to pulmonary congestion and fluid redistribution during sleep. Among patients with established HF, the presence of OSA has been linked to worse outcomes, including more frequent hospitalizations and higher mortality.
Despite this compelling evidence, the therapeutic potential of treating OSA in HF remains underexplored. While small studies suggest that short-term (3-6 months) treatment with continuous positive airway pressure (CPAP) in HF may improve cardiac function, adherence is suboptimal, with many patients unable to tolerate nightly use of CPAP. Given the rising prevalence of obesity, OSA and HF, there is an urgent need for well-tolerated, effective alternatives to CPAP. The mandibular advancement device (MAD) is an oral appliance approved for the treatment of OSA. Compared with CPAP, more patients accept MAD and use it for long-term with better adherence. Our team previously demonstrated in a randomized trial that MAD was associated with better adherence and improved nighttime blood pressure control compared to CPAP. In a pilot study of HF patients, the investigators found that treatment of OSA with MAD led to a reduction in plasma N-terminal pro-B-type natriuretic peptide (NT-proBNP)-a robust prognostic biomarker for HF
- Conditions
- Heart Failure, OSA - Obstructive Sleep Apnea
- Being tested
- Mandibular advancement device, Mandibular advancement device (Sham)
- Keywords
- heart failure, OSA, clinical trial, biomarker, quality of life
- Medical subject headings
- Heart Failure, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mandibular advancement deviceDevice
Mandibular advancement devices (MAD) and continuous positive airway pressure (CPAP) are non-surgical treatments for obstructive sleep apnea (OSA) that maintain upper airway patency during sleep. CPAP delivers pressurized air via a mask to splint the airway and is the gold-standard therapy, providing the greatest reduction in apnea-hypopnea index across all OSA severities. MADs are custom-made oral appliances that advance the mandible forward, enlarging the upper airway and reducing collapsibility, and are most effective in mild to moderate OSA.
Both therapies improve snoring, daytime sleepiness, and sleep quality, but differ in efficacy and tolerability. CPAP is more physiologically effective, while MADs are often better tolerated, more portable, and associated with higher real-world adherence. As a result, MADs are an accepted alternative for patients who cannot tolerate CPAP, with overall effectiveness influenced by both efficacy and adherence.
Mandibular advancement device (Sham)Device
Arm Description: The patients randomized to the sham MAD arm, the same MAD device as described above for the MAD arm will be used. Unlike an active MAD which advances the mandible to maintain airway patency, the sham-MAD is designed to resemble the real device while minimizing therapeutic effects. Its titration process ensures participant comfort while maintaining study blinding. The sham MAD is custom-fitted using standard dental impressions but is adjusted to allow only minimal mandibular protrusion (0-2 mm). During follow-up visits, minor, non-therapeutic adjustments are made to simulate an active titration process. These may involve small, inconsequential changes that do not significantly alter mandibular position.
| Study group | Role | What they receive |
|---|---|---|
| Mandibular advancement device | Experimental | The mandibular advancement device (MAD) is an oral appliance approved for the treatment of OSA. Compared with CPAP, more patients accept MAD and use it for long-term with better adherence. Our team previously demonstrated in a randomized trial that MAD was associated with better adherence and improved nighttime blood pressure control compared to CPAP Receives: Device: Mandibular advancement device |
| Mandibular advancement device (sham control) | Sham comparator | The patients randomized to the sham MAD arm, the same MAD device as described above for the MAD arm will be used. Unlike an active MAD which advances the mandible to maintain airway patency, the sham-MAD is designed to resemble the real device while minimizing therapeutic effects. Its titration process ensures participant comfort while maintaining study blinding. The sham MAD is custom-fitted using standard dental impressions but is adjusted to allow only minimal mandibular protrusion (0-2 mm). During follow-up visits, minor, non-therapeutic adjustments are made to simulate an active titration process. These may involve small, inconsequential changes that do not significantly alter mandibular position. Receives: Device: Mandibular advancement device (Sham) |
What is being measured
The primary outcome is the main question the study is designed to answer.
N-terminal pro-B-type natriuretic peptide (NT-pro BNP)
NT-proBNP (Primary endpoint) is a circulating biomarker released from the cardiac ventricles in response to myocardial wall stress and volume overload. It is commonly used to assess the presence and severity of heart failure. NT-proBNP levels are measured in picograms per milliliter (pg/mL). Higher values indicate greater cardiac wall stress and worse heart failure severity.
Measured: Baseline and 6 months (primary outcome)
Secondary outcomes (9)
Left ventricular ejection fraction (LVEF), expressed as percentage (%).
Transthoracic echocardiography determined parameters
Measured: Baseline and 6 months
Kansas City Cardiomyopathy Questionnaire (KCCQ).
Quality of life assessment tool for heart failure. The Overall Summary Score ranges from 0 to 100, with higher scores indicating better health status and quality of life.
Measured: Baseline, 6 months, and 12 months
Epworth Sleepiness Scale (ESS)
The Epworth Sleepiness Scale (ESS) is a self-administered questionnaire used to evaluate daytime sleepiness. The total score ranges from 0 to 24, with higher scores indicating greater daytime sleepiness.
Measured: Baseline, 6 months, and 12 months
Sleep Apnea Quality of Life Index (SAQLI)
The Sleep Apnea Quality of Life Index (SAQLI) is a disease-specific questionnaire assessing the impact of obstructive sleep apnea on daily functioning, social interactions, emotional functioning, and symptoms. The total score ranges from 1 to 7, with higher scores indicating better quality of life.
Measured: Baseline, 6 months, and 12 months
EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L)
The EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L) is a standardized instrument used to measure general health status across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The index score typically ranges from less than 0 (worse than death) to 1.0 (perfect health), with higher scores indicating better health status.
Measured: Baseline, 6 months, and 12 months
Montreal Cognitive Assessment (MoCA)
The Montreal Cognitive Assessment (MoCA) is a widely used screening tool for the assessment of global cognitive function, including domains such as attention, executive function, memory, language, visuospatial ability, abstraction, and orientation. The total score ranges from 0 to 30, with higher scores indicating better cognitive function. A score of 26 or above is considered normal cognitive function.
Measured: Baseline, 6 months, and 12 months
Adverse cardiovascular events
Adverse events. Although this trial is not powered to detect differences in hard clinical outcomes, we will collect them for exploratory analysis: hierarchical composite of death within 12 months after randomization and HF hospitalizations within 12 months after randomization.
Measured: 6 months, 12 months, and 36 months
Ambulatory BP monitoring
Ambulatory BP will be performed over a 24-hour period at baseline and 12 months. Key parameters will include 24-hour mean systolic and diastolic BP, daytime and nighttime averages, and nocturnal BP dipping patterns.
Measured: Baseline and 6 months
Peak oxygen uptake (VO₂peak)
Peak oxygen uptake (VO₂peak) is measured (one third of the participants) during cardiopulmonary exercise testing and reflects the maximum capacity of the body to transport and utilize oxygen during exercise, representing overall cardiorespiratory fitness. VO₂peak is expressed in mL/kg/min. Higher values indicate better cardiorespiratory fitness and exercise capacity.
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start1 May 2026 (estimated)
- Primary completion1 Apr 2031 (estimated)
- Study completion1 Apr 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by National University Hospital, 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
- Model description
- We designed a randomized, single-blind, placebo-controlled, outcome-assessor-blinded, superiority clinical trial (MARVEL-HF trial) to evaluate the efficacy of treating OSA (defined as AHI ≥15 events/hour) with MAD in reducing NT-proBNP levels in patients with HF. A sham MAD (same device, without mandibular advancement) will be used as the placebo control (standard practice, as in other clinical trials comparing MAD vs sham MAD). Due to the nature of the intervention, double blinding is not feasible. However, all outcome-assessors will be blinded to treatment allocation. The primary endpoint (plasma NT-proBNP level) is an objective measure.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 328 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Alexandra Hospital, Ng Teng Fong General Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07460505
- Sponsor's protocol ID
- ECOS Ref: 2025-1331
- Acronym
- MARVEL-HF
- Status last verified
- Jan 2026
- First submitted
- 23 Feb 2026
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon reasonable requests and obtained institution approval
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mandibular Advancement to Reduce Ventricular Load and Improve Quality of Life in Heart Failure - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07460505
- Acronym / sponsor ID
- MARVEL-HF / ECOS Ref: 2025-1331
- Conditions
- Heart Failure, OSA - Obstructive Sleep Apnea
- Keywords
- heart failure, OSA, clinical trial, biomarker, quality of life
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 328 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Collaborators
- Alexandra Hospital, Ng Teng Fong General Hospital
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 Apr 2031 (estimated)
- Study completion
- 1 Apr 2031 (estimated)
- First posted
- 10 Mar 2026 (actual)
- 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.
Heart failure with reduced ejection fraction (HFrEF) is a serious condition that limits daily activities and often leads to hospital stays and early death. Many patients with HFrEF also have obstructive sleep apnea (OSA), a common but often undiagnosed condition where breathing repeatedly stops during sleep. This causes drops in oxygen, poor sleep, and stress on the heart, which can make heart failure worse.
The investigators are studying whether a device called a mandibular advancement device (MAD)-a mouthpiece worn during sleep that keeps the airway open-can help people with both HFrEF and moderate-to-severe OSA. This device is already approved to treat OSA and is often more comfortable and easier to use than a CPAP machine.
In our study, 328 patients in Singapore will be randomly assigned to use either the MAD or a sham device that looks the same but doesn't move the jaw. They will wear the device for 12 months. We will measure changes in a blood marker linked to heart failure severity, as well as exercise ability, blood pressure, sleep quality, and hospital visits.
The investigators hope this study will show that MAD is a simple and patient-friendly way to improve outcomes in people with heart failure.
Detailed description
Heart failure profoundly impacts health, quality-of-life, and survival. Patients with heart failure (HF) experience fatigue, breathlessness, and exercise intolerance. Recurrent hospitalizations due to disease exacerbations further burden patients and healthcare systems. Despite advances in therapies, long-term outcomes remain poor with only 50% survival at 5 years post-diagnosis. Based on the left ventricular ejection fraction, HF is classified into three categories: reduced, mildly reduced, and preserved ejection fraction. This proposal focuses specifically on HF with reduced ejection fraction, which carries the worst prognosis. The term "HF" in this proposal refers exclusively to this subtype.
A growing body of evidence highlights the critical role of non-traditional and modifiable risk factors in heart failure progression, with obstructive sleep apnea (OSA) emerging as a particularly important contributor. OSA is highly prevalent in patients with HF, with estimates ranging from 40% to 70%. However, it remains substantially underdiagnosed and undertreated. OSA is characterized by repeated collapse of the upper airway during sleep, resulting in intermittent hypoxia, hypercapnia, serial arousals, and surges in sympathetic activity and blood pressure. These stressors contribute to elevated cardiac afterload, myocardial oxygen demand, and neurohormonal activation-all of which exacerbate ventricular dysfunction and HF progression. The relationship between OSA and HF is bidirectional. OSA not only contributes to the worsening of HF, but HF itself can increase the likelihood of OSA due to pulmonary congestion and fluid redistribution during sleep. Among patients with established HF, the presence of OSA has been linked to worse outcomes, including more frequent hospitalizations and higher mortality.
Despite this compelling evidence, the therapeutic potential of treating OSA in HF remains underexplored. While small studies suggest that short-term (3-6 months) treatment with continuous positive airway pressure (CPAP) in HF may improve cardiac function, adherence is suboptimal, with many patients unable to tolerate nightly use of CPAP. Given the rising prevalence of obesity, OSA and HF, there is an urgent need for well-tolerated, effective alternatives to CPAP. The mandibular advancement device (MAD) is an oral appliance approved for the treatment of OSA. Compared with CPAP, more patients accept MAD and use it for long-term with better adherence. Our team previously demonstrated in a randomized trial that MAD was associated with better adherence and improved nighttime blood pressure control compared to CPAP. In a pilot study of HF patients, the investigators found that treatment of OSA with MAD led to a reduction in plasma N-terminal pro-B-type natriuretic peptide (NT-proBNP)-a robust prognostic biomarker for HF
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- We designed a randomized, single-blind, placebo-controlled, outcome-assessor-blinded, superiority clinical trial (MARVEL-HF trial) to evaluate the efficacy of treating OSA (defined as AHI ≥15 events/hour) with MAD in reducing NT-proBNP levels in patients with HF. A sham MAD (same device, without mandibular advancement) will be used as the placebo control (standard practice, as in other clinical trials comparing MAD vs sham MAD). Due to the nature of the intervention, double blinding is not feasible. However, all outcome-assessors will be blinded to treatment allocation. The primary endpoint (plasma NT-proBNP level) is an objective measure.
| Arm | Type | Receives |
|---|---|---|
| Mandibular advancement device | Experimental | Device: Mandibular advancement deviceThe mandibular advancement device (MAD) is an oral appliance approved for the treatment of OSA. Compared with CPAP, more patients accept MAD and use it for long-term with better adherence. Our team previously demonstrated in a randomized trial that MAD was associated with better adherence and improved nighttime blood pressure control compared to CPAP |
| Mandibular advancement device (sham control) | Sham comparator | Device: Mandibular advancement device (Sham)The patients randomized to the sham MAD arm, the same MAD device as described above for the MAD arm will be used. Unlike an active MAD which advances the mandible to maintain airway patency, the sham-MAD is designed to resemble the real device while minimizing therapeutic effects. Its titration process ensures participant comfort while maintaining study blinding. The sham MAD is custom-fitted using standard dental impressions but is adjusted to allow only minimal mandibular protrusion (0-2 mm). During follow-up visits, minor, non-therapeutic adjustments are made to simulate an active titration process. These may involve small, inconsequential changes that do not significantly alter mandibular position. |
Who may qualify
- Ages
- 40 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age of at least 40 years old with the capacity to provide signed, written informed consent
- Ischemic or non-ischemic cardiomyopathy with a left ventricular ejection fraction of 20% to 40% in the previous 6 months
- Stable chronic HF with NYHA functional class I-III symptoms on maximally tolerated background therapy for at least 4 weeks
- NT-proBNP >600 pg/mL (for participants in sinus rhythm) or >900 pg/mL (for participants in atrial fibrillation) in the previous 6 months (same as leading HF trials)
- Agree to follow the study protocol
Key exclusion criteria (10 listed)
- Known OSA and already on regular treatment
- Moderate or severe valvular stenosis or regurgitation
- Severe hypoxemia on polysomnography ODI >60 or min SpO2 <60%
- Specific HF etiologies, including hypertrophic cardiomyopathy with left ventricular outflow tract obstruction; pericardial disease; infiltrative or inflammatory myocardial disease; valvular heart disease with severe aortic or primary mitral regurgitation, moderate or severe aortic stenosis, any mitral stenosis requiring surgical repair, or active endocarditis
- Contraindications to MAD: less than six teeth in each arch; inability to advance the mandible and open the jaw widely.
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 |
|---|---|---|
| Mandibular advancement deviceMandibular advancement devices (MAD) and continuous positive airway pressure (CPAP) are non-surgical treatments for obstructive sleep apnea (OSA) that maintain upper airway patency during sleep. CPAP delivers pressurized air via a mask to splint the airway and is the gold-standard therapy, providing the greatest reduction in apnea-hypopnea index across all OSA severities. MADs are custom-made oral appliances that advance the mandible forward, enlarging the upper airway and reducing collapsibility, and are most effective in mild to moderate OSA. Both therapies improve snoring, daytime sleepiness, and sleep quality, but differ in efficacy and tolerability. CPAP is more physiologically effective, while MADs are often better tolerated, more portable, and associated with higher real-world adherence. As a result, MADs are an accepted alternative for patients who cannot tolerate CPAP, with overall effectiveness influenced by both efficacy and adherence. | Device | Mandibular advancement device |
| Mandibular advancement device (Sham)Arm Description: The patients randomized to the sham MAD arm, the same MAD device as described above for the MAD arm will be used. Unlike an active MAD which advances the mandible to maintain airway patency, the sham-MAD is designed to resemble the real device while minimizing therapeutic effects. Its titration process ensures participant comfort while maintaining study blinding. The sham MAD is custom-fitted using standard dental impressions but is adjusted to allow only minimal mandibular protrusion (0-2 mm). During follow-up visits, minor, non-therapeutic adjustments are made to simulate an active titration process. These may involve small, inconsequential changes that do not significantly alter mandibular position. | Device | Mandibular advancement device (sham control) |
Primary outcome
N-terminal pro-B-type natriuretic peptide (NT-pro BNP)
Time frame: Baseline and 6 months (primary outcome)
NT-proBNP (Primary endpoint) is a circulating biomarker released from the cardiac ventricles in response to myocardial wall stress and volume overload. It is commonly used to assess the presence and severity of heart failure. NT-proBNP levels are measured in picograms per milliliter (pg/mL). Higher values indicate greater cardiac wall stress and worse heart failure severity.
9 secondary outcomes
Left ventricular ejection fraction (LVEF), expressed as percentage (%).
Time frame: Baseline and 6 months
Kansas City Cardiomyopathy Questionnaire (KCCQ).
Time frame: Baseline, 6 months, and 12 months
Epworth Sleepiness Scale (ESS)
Time frame: Baseline, 6 months, and 12 months
Sleep Apnea Quality of Life Index (SAQLI)
Time frame: Baseline, 6 months, and 12 months
EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L)
Time frame: Baseline, 6 months, and 12 months
Montreal Cognitive Assessment (MoCA)
Time frame: Baseline, 6 months, and 12 months
Adverse cardiovascular events
Time frame: 6 months, 12 months, and 36 months
Ambulatory BP monitoring
Time frame: Baseline and 6 months
Peak oxygen uptake (VO₂peak)
Time frame: Baseline and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Individual participant dataSharing planned: Yes. Upon reasonable requests and obtained institution approval
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mandibular advancement device in people with Heart Failure and OSA - Obstructive Sleep Apnea, run by National University Hospital, 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 6 inclusion and 10 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: opening soon, as of the sponsor's last update on 10 Mar 2026. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chi-Hang Ronald Lee, MBBS, MD (+6567722493 ext. 2493, mdclchr@nus.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
N-terminal pro-B-type natriuretic peptide (NT-pro BNP) (time frame: Baseline and 6 months (primary outcome)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Mar 2026.