Miniscrew-Assisted Rapid Palatal Expansion for Obstructive Sleep Apnea

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.

Conditions

• OSA - Obstructive Sleep Apnea
• Palatal Expansion Technique

Interventions

DEVICE

Miniscrew-Assisted Rapid Palatal Expansion

This intervention uses a standardized miniscrew-assisted rapid palatal expansion (MARPE) protocol to achieve maxillary expansion in skeletally mature patients with obstructive sleep apnea. Unlike conventional tooth-borne rapid maxillary expansion (RME), MARPE is designed to achieve more skeletal expansion and reduce unwanted dental effects. Compared with surgically assisted expansion techniques such as SARPE and DOME, this intervention is non-surgical and focuses on correcting transverse maxillary deficiency as a contributing anatomical factor in upper airway narrowing.

OTHER

Standard Care (in control arm)

This control group is a 3-month wait-list standard care arm for obstructive sleep apnea (OSA). During the trial period, participants will receive conservative and physician-directed management only, including lifestyle advice (e.g., weight management, sleep hygiene, positional therapy, and avoidance of alcohol or sedatives before sleep), medical management if indicated, and treatment of nasal obstruction as appropriate (e.g., topical nasal steroids or antihistamines). Participants will be monitored every 4 weeks and may receive rescue CPAP if clinically indicated. Unlike the experimental arm, no active maxillary expansion will be provided during the waiting period; MARPE will be offered after the 3-month assessment if they wish to undergo treatment.

Sponsors & Collaborators

• University of Malaya

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

16 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-08-01

Primary Completion

2027-02-20

Completion

2027-02-20