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A mouthpiece worn during sleep for people with heart failure and sleep apnea

Tests a sleep mouthpiece in people with heart failure and obstructive sleep apnea.

Key facts

Who runs it
National University Hospital, Singapore
Where
Singapore, SingaporeSee the site
Trial code
Registry title
Mandibular Advancement to Reduce Ventricular Load and Improve Quality-of-life in Heart Failure
Status
Not yet recruiting
People taking part
328 people, planned
Started
1 May 2026
Expected to end
1 Apr 2031
Type of study
Interventional, 2 groupsOne group gets a sham (pretend) treatment, for comparison.
Treatments tested
  • Mandibular advancement device
  • Mandibular advancement device (Sham)
Record updated
10 March 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 40 or older with stable heart failure with reduced pumping strength and sleep apnea. They will wear a mouthpiece (real or sham) during sleep for 12 months.

Age
40 to 99 years
Sex
All sexes
Disease stage
Stable long-term heart failure, NYHA class I-III, with a left ventricular ejection fraction of 20% to 40% in the previous 6 months. Moderate-to-severe obstructive sleep apnea.
Earlier treatment
Must be on the highest heart failure treatment they can tolerate for at least 4 weeks. Cannot already be on regular treatment for known sleep apnea.
Biomarker or test result
NT-proBNP above 600 pg/mL if in sinus rhythm, or above 900 pg/mL if in atrial fibrillation, in the previous 6 months.

Main reasons for not taking part

  • Known sleep apnea already on regular treatment
  • Moderate or severe heart valve narrowing or leaking, or other specific causes of heart failure
  • Heart or brain events such as heart attack or stroke in the past 6 months
  • Jaw, teeth or gum problems that make a mouthpiece unsafe, or dental work planned in the next 12 months
  • Life expectancy under one year, dialysis, heart transplant or mechanical heart support

The registry criteria, word for word

Show all 16 criteriaShow less

Who can take part

  • 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 take part

  • Patients who are planning to have restorations, dental prostheses or implants done in the next 12 months
  • 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
  • Pre-existing temporomandibular joint problems, severe bruxism, and advanced periodontal disease (with mobility affecting MAD stability)
  • 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
  • Known OSA and already on regular treatment
  • Moderate or severe valvular stenosis or regurgitation
  • Severe hypoxemia on polysomnography ODI >60 or min SpO2 <60%
  • Contraindications to MAD: less than six teeth in each arch; inability to advance the mandible and open the jaw widely
  • Limited life expectancy (< one year)

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 40 and 99 years old?

Where in Singapore

  • National University HospitalSingapore, SingaporeContact: Chi-Hang Ronald Lee, MDNot yet recruiting

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 2 groups in the trial

  • Mandibular advancement deviceTreatment being tested

    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

  • Mandibular advancement device (sham control)Sham treatment, for comparison

    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.

    Treatment: Mandibular advancement device (Sham)

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Mandibular Advancement to Reduce Ventricular Load and Improve Quality of Life in Heart Failure - a Randomized Controlled Trial
Plain-language title
A mouthpiece worn during sleep for people with heart failure and sleep apneaGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT07460505, who can take part
Record updated
10 March 2026