Effects of Two Different Amounts of Mandibular Protrusion in Obstructive Sleep Apnea Patients Using Mandibular Advancement Appliance : A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in Apnea-hypopnea index (AHI)
研究概览
简要总结
Obstructive sleep apnea (OSA) is a complex disease associated with repeated closure of the upper airway during sleep which causes excessive daytime sleepiness. Daytime sleepiness can affects daytime performance undesirably and reduces driving performance causing an increased risk for accidents. It can also lead to high blood pressure, strokes, and eventually death.
Until now, there is no standardize value for the jaw advancement for the mandibular advancement appliance. It was found that when comparing the jaw advancement amount of 50% and above 50%, there is no additional efficacy. Efficacy of jaw advancement below 50% is lacking. Patients usually experience more complications with more advancement, there the investigators need to study the optimal mandibular advancement with least complication to the patients.
详细描述
This is a single-center, double blind (patients and sleep analyst) prospective randomized controlled trial to be conducted at Faculty of Dentistry, University of Malaya.
Eligible and consented patients will be randomized into three groups using block randomization with allocation concealment. Patients in Group 1 and 2 will receive MAA set at 25%, 50% of maximum mandibular advancement respectively.
A general medical history will be recorded. Demographic data will be obtained from patients. Baseline measurements will be recorded as T0.
Alginate impressions of the upper and lower dental arches will be taken. Respective mandibular advancement record i.e. at 25% and 50% as assigned by block randomization will be registered using George Gauge. Monobloc type of MAA will then be custom-made for each patient.
Upon issue of MAA, patients will be given detailed instructions for the insertion, removal, storage, and maintenance of MAA. Patients will be advised to wear the MAA every night during sleep. Each patient will be reviewed one week after issue to assess for any problems encountered, adjust the MAA for comfort, and reinforce wear for compliance. Subsequent follow up will be scheduled at every 4-6 weeks. 6 months later, outcome measurements will be recorded as T1.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Patients will be blinded to the intervention allocation and intervention group. A single orthodontic resident will treat all the patients, and one dental technician will construct all the appliances. The clinician, however, is unable to be blinded due to the need to prescribe the MAA as being randomized. Data collection and analysis will be done by the orthodontic resident. Blinding during data collection will not possible but after data collection, all the data will be coded before being processed and analysed, ensuring blinding of this stage of study. Sleep technician and physician who respectively carried out and analysed the polysomnography will be blinded to the treatment assignment. Statistician who analysed the data will also blinded to the group of treatment.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mild and moderate OSA patients who are keen on MAA
- •Severe OSA who had refuse CPAP
- •Aged 18 years and older
- •Without any form of prior treatment
- •Absence of any structural obstruction examined by otolaryngologist
- •Sufficient set of teeth to hold the appliance
排除标准
- •Presence of periodontal disease
- •Exaggerated gag reflex and temporomandibular joint disorder
- •Significant co-morbidity that could endanger the patient's health
- •Any psychiatric or neurological diseases previously known that could impair the compliance
- •Any medication intake that can influence sleep
- •Co-existing sleep disorders other than OSA for instance insomnia, central sleep apnea and etc
- •Pregnant candidates
结局指标
主要结局
Change in Apnea-hypopnea index (AHI)
时间窗: 6 months
Apnea Hypopnea Index (AHI) is one of the parameters obtained from polysomnography(PSG) to determine the severity of obstructive sleep apnoea. The AHI is the number of apneas or hypopneas recorded during the study per hour of sleep. It is generally expressed as the number of events per hour. Based on the AHI, the severity of OSA is classified as follows: None/Minimal: AHI \< 5 per hour; Mild: AHI ≥ 5, but \< 15 per hour; Moderate: AHI ≥ 15, but \< 30 per hour and Severe: AHI ≥ 30 per hour. For comparison with other studies, we will also calculate the percentage of patients achieving: (1) reduction in AHI ≥50%; (2) AHI \<10; and (3) AHI \<5, together with the success criteria defining complete response(CR) as resolution of symptoms and outcome AHI \<5, and partial response(PR) as improvement of symptoms and reduction in AHI ≥50% but outcome AHI ≥5. Failure(F) was defined as a reduction in AHI \<50% and ⁄ or ongoing symptoms.
次要结局
- Change in Blood Pressure(6 months)
- Change in Epworth Sleepiness Scale (ESS)(6 months)
- Change in minimum oxygen saturation (MinSaO2)(6 months)
- Change in Quality of Life: Calgary Sleep Apnea Quality of Life Index (SAQLI)(6 months)
- Compliance of wearing the mandibular advancement appliance(MAA)(6 months)
- Secondary effects of wearing mandibular advancement appliance(MAA)(6 months)
- Dental changes after wearing mandibular advancement appliance(MAA)-overjet, overbite, intercanine width, intermolar width and arch length(6 months)
- Dental changes after wearing mandibular advancement appliance(MAA)-Little's irregularity Index(6 months)
研究者
Dr Chin Mei H'uah
Postgraduate Student
University of Malaya