Miniscrew-Assisted Rapid Palatal Expansion for Obstructive Sleep Apnea
NCT: NCT07734688 · NOT_YET_RECRUITING
Brief 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.
Frequently Asked Questions
What is Miniscrew-Assisted Rapid Palatal Expansion for Obstructive Sleep Apnea?
Miniscrew-Assisted Rapid Palatal Expansion for Obstructive Sleep Apnea is a clinical trial registered under NCT07734688. Current status: NOT_YET_RECRUITING.
What is the status of NCT07734688?
The current status of NCT07734688 (Miniscrew-Assisted Rapid Palatal Expansion for Obstructive Sleep Apnea) is: NOT_YET_RECRUITING.
When did Miniscrew-Assisted Rapid Palatal Expansion for Obstructive Sleep Apnea start?
Miniscrew-Assisted Rapid Palatal Expansion for Obstructive Sleep Apnea started on 2026-08-01.
Related Devices
Official Source
View on ClinicalTrials.gov →Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.