Health Outcomes of Treatment of Obstructive Sleep Apnea With Dental Devices
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Treatment of OSA with mandibular advancement device results in improvements in insulin sensitivity
研究概览
简要总结
This study is being done to see if treatment of obstructive sleep apnea (OSA) with a mandibular advancement device (MAD) shows an increase in the quality of life. Many patients prefer to call them mandibular advancers, jaw advancers, jaw advancement splints, jaw advancement devices, anti-snoring mouthpieces, or oral appliances for the treatment of snoring and mild to moderate obstructive sleep apnea. The investigators will also see how helpful the mandibular advancement device is on insulin resistance.
详细描述
Patients with obstructive sleep apnea (OSA) will be included in this prospective controlled trial. OSA patients who are unable to tolerate CPAP or refuse CPAP(Continuous positive airway pressure) (and who are deemed appropriate by their attending physician for dental device treatment of OSA will be randomized to a control group (no MAD treatment) or to active MAD therapy.
Epidemiologic studies suggest that OSA is associated with insulin resistance independent of other known risk factors such as obesity. The cyclic intermittent hypoxia in OSA is the primary stimulus that leads to insulin resistance, a primary risk factor for the development of type 2 diabetes. There is an association between the level of hypoxic stress in OSA and insulin resistance.
The overall hypothesis to be tested is that treatment of OSA with MAD will improve insulin sensitivity, increase levels of HMW (High-molecular- weight) adiponectin, and improve psychological adjustment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Device Feasibility
- 盲法
- None
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
- •Apnea-hypopnea index (AHI) of at least 20 events/hr based on overnight polysomnography
- •> 18 years of age
- •Unable to tolerate or refuse CPAP treatment
排除标准
- •Known diabetes mellitus
- •Body mass index (BMI) > 45 kg/m2
- •Uncontrolled hypertension
- •Known congestive heart failure
- •Use of illicit drugs
- •Excessive alcohol consumption, defined as:
- •More than 3 glasses of wine a day
- •More than 3 beers a day
- •More than 60 mL of hard liquor a day
- •Room air oxyhemoglobin saturation < 90%
- •Use of home oxygen
- •Use of corticosteroids
- •Unable to give voluntary consent
结局指标
主要结局
Treatment of OSA with mandibular advancement device results in improvements in insulin sensitivity
时间窗: 16 weeks
次要结局
- Treatment of OSA with mandibular advancement device increases the levels of high-molecular-weight adiponectin in the circulation(16 weeks)
- Treatment of OSA with mandibular advancement device improves psychological adjustment.(16 weeks)
研究者
Ulysses Magalang MD
Professor-Clinical
Ohio State University