Efficacy of Different Treatment Modalities for Obstructive Sleep Apnea: a Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Apnea hypopnea index
研究概览
简要总结
This was a prospective randomized controlled clinical trial that aimed to evaluate the efficacy of three treatments for obstructive sleep Apnea OSA:
- Conventionally constructed mandibular advancement device (MAD).
- Digitally constructed mandibular advancement device (CAD CAM).
- Uvulopalatopharyngeoplasty (UPPP).
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
- None
入排标准
- 年龄范围
- 30 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adequate nasal air flow capacity as determined by qualified otolaryngologist
- •Cases showing improvement in airway with mandibular advancement on Acoustic Pharyngometry (AP)
- •Patients with the minimum component of dentition to support MDSA.
- •Patients with the mandibular protrusive movement of more than 5 mm
- •Body mass index (BMI) less than 30 kg/m2
排除标准
- •Severe nasal passage obstructions or allergies
- •Obesity (BMI greater than 30 kg/m2 )
- •Cases with Mallampati score greater than Class 1
- •Systemic complications, syndrome, or disease affecting airway
- •Severe periodontal disease
结局指标
主要结局
Apnea hypopnea index
时间窗: 4 months
The AHI measures an average number of apnea and hypopnea episodes that you experience per hour. According to the American Academy of Sleep Medicine (AASM) it is categorized into mild (5-15 events/hour), moderate (15-30 events/hr), and severe (\> 30 events/hr)
Epwoth sleeplness scale (ESS)
时间窗: 4 months
The ESS is a subjective measure of a patient's sleepiness. The test is a list of eight situations in which the patien rates their tendency to become sleepy on a scale of 0, no chance of dozing, to 3, high chance of dozing. All scores on the ESS fall between 0 and 24. Scores from 0 to 10 reflect normal levels of daytime sleepiness, and scores over 10 are considered to reflect excessive daytime sleepiness.
Oxygen saturation
时间窗: 4 months
This will be measured using an oximeter. A normal level of oxygen is usually 95% or higher.
Snoring index
时间窗: 4 months
Snoring index measures the total number of snores per hour of sleep. This is calculated by dividing your total sleeping time by your snoring frequency. The normal range depends on the person's gender and the stage of sleep
次要结局
未报告次要终点
研究者
Nourhan M.Aly
Assistant Lecturer of Dental Public Health
University of Alexandria