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Jaw-Widening device may ease sleep apnea without surgery

NCT ID NCT07734688

Disease control Sponsor: University of Malaya Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 29, 2026 · Last updated Jul 30, 2026 · Updated 1 time

Summary

This trial tests whether a miniscrew-assisted rapid palatal expander (MARPE) can reduce obstructive sleep apnea severity in people aged 16 to 60. Participants are randomly assigned to receive either standard care alone or standard care plus the expander, which widens the upper jaw over three months. Researchers measure changes in breathing during sleep, daytime sleepiness, and quality of life to see if the device offers added benefit.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a dental device called a miniscrew-assisted rapid palatal expander (MARPE) that widens the upper jaw
What this could lead to
If it works, MARPE could offer a non-surgical way to improve breathing and reduce sleep apnea severity in adults.
What could go wrong
This is a small early trial with only 24 participants, so results may not apply to everyone. The device requires daily activation and may cause discomfort or dental side effects.

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 24 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Feb 2027

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

16 to 60 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: 1. AHI ≥ 5 2. Aged ≥ 16 and ≤ 60 years old 3. Presence of the upper first permanent molars 4. Presence of unilateral or bilateral posterior crossbite or maxillary transverse deficiency (considering intermolar width measurements, posterior teeth buccolingual incli- nation, and posterior crossbites) allowing meaningful maxillary expansion of at least 5mm 5. Willingness to undergo MARPE treatment under the standard fee structure of the Faculty of Dentistry, Universiti Malaya Exclusion Criteria: 1. BMI ≥ 30 kg/m2 2. Basic Periodontal Examination (BPE) ≥ 3 or BPE markers\* (root bifurcation lesions) 3. Mobile teeth (Mobility grade ≥ 1) 4. Pathology in the maxilla, such as substantial maxillary bone defects, or maxillary bone defects due to space-occupying cysts, tumors, etc. 5. Significant true skeletal asymmetry 6. Presence of significant root resorption of upper first permanent molars due to previous orthodontic treatments 7. Concurrent on-going treatment for OSA such CPAP 8. Previous treatment for OSA such as soft tissue or hard tissue surgery within the past 4 months 9. Significant mandibular retrognathic (SNB less than normal value cephalometrically) 10. General chronic medical illnesses like cardiac failure, kidney failure, stroke etc. 11. Medication 12. Syndromic 13. Presence of neuropsychiatric illnesses such insomnia, narcolepsy, parasomnia etc. 14. Presence of neuromuscular diseases such multiple schlerosis, epilepsy, Parkinson's disease. \-

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Conditions

The condition(s) this trial relates to.

obstructive sleep apnea syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

OSA - obstructive sleep apnea Palatal expansion technique

How to take part

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  1. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  2. A doctor treating you

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