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NCT07734688
Miniscrew-Assisted Rapid Palatal Expansion for Obstructive Sleep Apnea
Conditions: OSA - Obstructive Sleep Apnea, Palatal Expansion Technique
Sex: All
Ages: 16 Years – 60 Years
Healthy volunteers: No
Phase: NA
Enrollment: 24
Sponsor: University of Malaya
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.
Eligibility Criteria
Inclusion Criteria:
1. AHI ≥ 5
2. Aged ≥ 16 and ≤ 60 years old
3. Presence of the upper first permanent molars
4. 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
5. Willingness to undergo MARPE treatment under the standard fee structure of the Faculty of Dentistry, Universiti Malaya
Exclusion Criteria:
1. BMI ≥ 30 kg/m2
2. Basic Periodontal Examination (BPE) ≥ 3 or BPE markers\* (root bifurcation lesions)
3. Mobile teeth (Mobility grade ≥ 1)
4. Pathology in the maxilla, such as substantial maxillary bone defects, or maxillary bone defects due to space-occupying cysts, tumors, etc.
5. Significant true skeletal asymmetry
6. Presence of significant root resorption of upper first permanent molars due to previous orthodontic treatments
7. Concurrent on-going treatment for OSA such CPAP
8. Previous treatment for OSA such as soft tissue or hard tissue surgery within the past 4 months
9. Significant mandibular retrognathic (SNB less than normal value cephalometrically)
10. General chronic medical illnesses like cardiac failure, kidney failure, stroke etc.
11. Medication
12. Syndromic
13. Presence of neuropsychiatric illnesses such insomnia, narcolepsy, parasomnia etc.
14. Presence of neuromuscular diseases such multiple schlerosis, epilepsy, Parkinson's disease.
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Source: ClinicalTrials.gov (NCT07734688). StuddyBuddy aggregates publicly available trial information.