Clinical Trial

Miniscrew-Assisted Rapid Palatal Expansion for Obstructive Sleep Apnea

Not Yet Recruiting
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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.
Trial Details
NCT Number NCT07734688
Lead Sponsor University of Malaya
Conditions OSA - Obstructive Sleep Apnea, Palatal Expansion Technique
Enrollment 24 participants
Start Date 2026-08-01
Primary Completion 2027-02-20 (estimated)
Study Completion 2027-02-20 (estimated)
Updated on ClinicalTrials.gov 2026-07-29