The Effectiveness of Miniscrew-Assisted Rapid Palatal Expansion in the Management of Obstructive Sleep Apnea: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 24
- 主要终点
- Apnea Hyponea Index(AHI)
研究概览
简要总结
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:
- 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?
- 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:
- Receive standard care for obstructive sleep apnea
- Be randomly assigned to either MARPE plus standard care or standard care alone for 3 months
- In the MARPE group, wear a miniscrew-assisted rapid palatal expander and activate it according to the study protocol
- Visit the clinic for follow-up care and monitoring
- 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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The operator and participants will not be able to be blinded due to the nature of the study. Similarly, blinding of data collection for CBCT, ESS and FOSQ-10 is not feasible either. However, HSAT report synthesization will be blinded. As for data analysis, all data collected will be coded to enable blinding.
入排标准
- 年龄范围
- 16 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
- •Presence of neuropsychiatric illnesses such insomnia, narcolepsy, parasomnia etc.
- •Presence of neuromuscular diseases such multiple schlerosis, epilepsy, Parkinson's disease.
结局指标
主要结局
Apnea Hyponea Index(AHI)
时间窗: "From treatment begin/recruited to the end of treatment/recruited at 3 months"
次要结局
- Cone Beam Computed Tomography("From treatment begin/ recruited to the end of treatment/recruited at 3 months")
- Epworth Sleepiness Scale("From treatment begin/ recruited to the end of treatment/recruited at 3 months")
- Functional Outcomes of Sleep Questionnaire Short Version("From treatment begin/ recruited to the end of treatment/recruited at 3 months")
- Peak Nasal Inspiratory Flow("From treatment begin/recruited to the end of treatment/recruited at 3 months")
研究者
LI QIANYU
Principal Investigator
University of Malaya