Simple mouthpiece could ease heart strain in sleep apnea patients
NCT ID NCT07460505
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests if a mouthpiece worn during sleep can help people with both heart failure and obstructive sleep apnea. The device keeps the airway open, which may reduce stress on the heart and improve quality of life. 328 participants will use either the real device or a sham one for 12 months. Researchers will measure heart strain, exercise ability, and hospital visits.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 328 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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May 2026
An estimate. Start dates often move.
- Expected to finish
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Apr 2031
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 to 99 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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National University Hospital
Singapore, Kent Ridge, 119228, Singapore
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Other studies related to the condition(s) this trial covers.
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- Can daily mindful breathing ease heart failure symptoms?
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