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NCT07460505

Mandibular Advancement to Reduce Ventricular Load and Improve Quality-of-life in Heart Failure

Sponsor: National University Hospital, Singapore

View on ClinicalTrials.gov

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. 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.

Official title: Mandibular Advancement to Reduce Ventricular Load and Improve Quality of Life in Heart Failure - a Randomized Controlled Trial

Key Details

Gender

All

Age Range

40 Years - 99 Years

Study Type

INTERVENTIONAL

Enrollment

328

Start Date

2026-05-01

Completion Date

2031-04-01

Last Updated

2026-03-10

Healthy Volunteers

Conditions

Heart Failure OSA - Obstructive Sleep Apnea

Interventions

DEVICE

Mandibular advancement device

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.

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.

Inclusion Criteria: * 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 Exclusion Criteria: * 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). * 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

Locations (1)

National University Hospital

Singapore, Kent Ridge, Singapore