Not Yet RecruitingNot Applicable

Miniscrew-Assisted Rapid Palatal Expansion for Obstructive Sleep Apnea

24 participantsStarted 2026-08-01

Plain-language summary

The goal of this clinical trial is to learn whether miniscrew-assisted rapid palatal expansion (MARPE) can improve obstructive sleep apnea (OSA) in late adolescents and adults aged 16 to 60 years. The main questions it aims to answer are: 1. Does MARPE improve sleep apnea severity, as measured by Home Sleep Apnea Testing (HSAT), including respiratory event index (REI), oxygen desaturation index (ODI), mean oxygen saturation, nadir oxygen saturation, snoring events, and body position? 2. Does MARPE improve breathing and sleep-related symptoms, including upper airway dimensions, daytime sleepiness, quality of life, and peak nasal inspiratory flow (PNIF)? Researchers will compare a MARPE group with a control group that receives standard care for obstructive sleep apnea for 3 months to see whether MARPE provides additional benefit. Participants will: 1. Receive standard care for obstructive sleep apnea 2. Be randomly assigned to either MARPE plus standard care or standard care alone for 3 months 3. In the MARPE group, wear a miniscrew-assisted rapid palatal expander and activate it according to the study protocol 4. Visit the clinic for follow-up care and monitoring 5. Data will be collected at baseline (T0) and 3 months (T1). At both time points, participants in the MARPE group will be assessed using Home Sleep Apnea Testing (HSAT), cone beam computed tomography (CBCT), Epworth Sleepiness Scale (ESS), Functional Outcomes of Sleep Questionnaire Short Version (FOSQ-10), and peak nasal inspiratory flow (PNIF). Participants in the control group will be assessed using HSAT, ESS, FOSQ-10, and PNIF.

Who can participate

Age range

16 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. AHI ≥ 5
. Aged ≥ 16 and ≤ 60 years old
. Presence of the upper first permanent molars
. 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
. Willingness to undergo MARPE treatment under the standard fee structure of the Faculty of Dentistry, Universiti Malaya

Exclusion criteria

. BMI ≥ 30 kg/m2

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Apnea Hyponea Index(AHI)

Timeframe: "From treatment begin/recruited to the end of treatment/recruited at 3 months"

Trial details

NCT IDNCT07734688

SponsorUniversity of Malaya

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-02-20

View on ClinicalTrials.gov More OSA - Obstructive Sleep Apnea trials