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Simple mouthpiece could ease heart strain in sleep apnea patients

NCT ID NCT07460505

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

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

About 328 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Apr 2031

An estimate. End dates often move.

Lead sponsor

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

40 to 99 years

Sex

Anyone

Healthy volunteers

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

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

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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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  3. A doctor treating you

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Contacts and locations

Locations

  • National University Hospital

    Singapore, Kent Ridge, 119228, Singapore

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Other studies related to the condition(s) this trial covers.