Miniscrew-Assisted Rapid Palatal Expansion for Obstructive Sleep Apnea

Официальное название

The Effectiveness of Miniscrew-Assisted Rapid Palatal Expansion in the Management of Obstructive Sleep Apnea: A Randomized Controlled Clinical Trial

Обзор

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.

Подробное описание

This is a single-blind, double-arm, parallel-group randomized controlled trial designed to evaluate the effectiveness of miniscrew-assisted rapid palatal expansion (MARPE) in late adolescents and adults with obstructive sleep apnea (OSA). A total of 24 participants aged 16 to 60 years will be enrolled if they meet the study criteria. Eligible participants must have OSA, as shown by an apnea-hypopnea index (AHI) of 5 or higher, and must also have maxillary transverse deficiency, such as posterior crossbite or reduced maxillary intermolar width. Participants with severe obesity, active periodontal problems, mobile teeth, major maxillary pathology, previous orthodontic treatment, or recent OSA treatment will not be included.

Participants will be assigned by gender-stratified block randomization in a 1:1 ratio to either the test group or the control group. The test group will receive MARPE with standard care for OSA. The control group will receive standard care for OSA for 3 months and will be offered MARPE after the 3-month assessment if they wish to undergo treatment.

The MARPE device used in this study is the Maxillary Skeletal Expander II. Expansion will begin according to the manufacturer's instructions until a median diastema appears, and then the screw will be activated two turns per day until overcorrection is reached. After expansion, the appliance will remain in place for 6 months as retention to allow bone formation.

Data will be collected at baseline before the start of treatment (T0) and three months after the completion of expansion (T1). At both T0 and T1 the test group will undergo assessment 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); the control group will undergo assessment using HSAT, ESS, FOSQ-10 and PNIF.

Вмешательства

• Устройство 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 maxilla
• Другое 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 monito

Первичные конечные точки

• Apnea Hyponea Index(AHI) [Срок оценки: "From treatment begin/recruited to the end of treatment/recruited at 3 months"]

Вторичные конечные точки (4)

• Cone Beam Computed Tomography [Срок оценки: "From treatment begin/ recruited to the end of treatment/recruited at 3 months"]
• Epworth Sleepiness Scale [Срок оценки: "From treatment begin/ recruited to the end of treatment/recruited at 3 months"]
• Functional Outcomes of Sleep Questionnaire Short Version [Срок оценки: "From treatment begin/ recruited to the end of treatment/recruited at 3 months"]
• Peak Nasal Inspiratory Flow [Срок оценки: "From treatment begin/recruited to the end of treatment/recruited at 3 months"]

Критерии участия

Критерии включения

• 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
• Willingness to undergo MARPE treatment under the standard fee structure of the Faculty of Dentistry, Universiti Malaya

Критерии исключения

• 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.
• Significant true skeletal asymmetry
• Presence of significant root resorption of upper first permanent molars due to previous orthodontic treatments
• Concurrent on-going treatment for OSA such CPAP
• Previous treatment for OSA such as soft tissue or hard tissue surgery within the past 4 months
• Significant mandibular retrognathic (SNB less than normal value cephalometrically)
• General chronic medical illnesses like cardiac failure, kidney failure, stroke etc.
• Medication
• Syndromic
• Presence of neuropsychiatric illnesses such insomnia, narcolepsy, parasomnia etc.
• Presence of neuromuscular diseases such multiple schlerosis, epilepsy, Parkinson's disease.

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Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07734688 · DF CD2605/0015 (P)

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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