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Miniscrew-Assisted Rapid Palatal Expansion for Obstructive Sleep Apnea

ConditionsOSA - Obstructive Sleep ApneaPalatal Expansion Technique
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16-60
SponsorUniversity of Malaya

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

BMI ≥ 30 kg/m2

Basic Periodontal Examination (BPE) ≥ 3 or BPE markers* (root bifurcation lesions)

Mobile teeth (Mobility grade ≥ 1)

Pathology in the maxilla, such as substantial maxillary bone defects, or maxillary bone defects due to space-occupying cysts, tumors, etc.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Miniscrew-Assisted Rapid Palatal Expansion

    Device

    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.

  • Standard Care (in control arm)

    Other intervention

    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.

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: MARPEExperimental treatment 1 intervention
Group B: Wait-list ControlOther 1 intervention

Trial outcomes

Primary outcomes

1

Apnea Hyponea Index(AHI)

Time frame
"From treatment begin/recruited to the end of treatment/recruited at 3 months"

Secondary outcomes

1

Cone Beam Computed Tomography

Time frame
"From treatment begin/ recruited to the end of treatment/recruited at 3 months"
2

Epworth Sleepiness Scale

Time frame
"From treatment begin/ recruited to the end of treatment/recruited at 3 months"
3

Functional Outcomes of Sleep Questionnaire Short Version

Time frame
"From treatment begin/ recruited to the end of treatment/recruited at 3 months"
4

Peak Nasal Inspiratory Flow

Time frame
"From treatment begin/recruited to the end of treatment/recruited at 3 months"

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Malaya

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: