Occlusal Stabilization Splints and Sleep Disordered Breathing
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Change in abdomen plethysmography as measured by the MediByte device
研究概览
简要总结
The purpose of this study is to investigate the effects of mandibular occlusal stabilization splint (OSS) and modified farrar splint on sleep bruxism and respiratory indices and the effects of occlusal splints on the airway volume through imaging.
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)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed with sleep bruxism
- •prescribed an occlusal splint
排除标准
- •Less than 18 years old
- •Secondary obstructive sleep apnea diagnosis
- •Genetic disease that contributes to possible secondary obstructive sleep apnea
- •Patient refuses to sign informed consent document
- •Patient does not speak or read English
- •More than two missing posterior teeth (excluding third molars)
- •Presence of gross malocclusion
结局指标
主要结局
Change in abdomen plethysmography as measured by the MediByte device
时间窗: Baseline(without device),with device
Change in peripheral capillary oxygen saturation (SpO2) as measured by the MediByte device
时间窗: Baseline(without device),with device
Change in masticatory muscle activity as measured by the MediByte device
时间窗: Baseline(without device),with device
Change in chest plethysmography as measured by the MediByte device
时间窗: Baseline(without device),with device
Change in pulse as measured by the MediByte device
时间窗: Baseline(without device),with device
Change in airflow as measured by the MediByte device
时间窗: Baseline(without device),with device
次要结局
- Change in airway anatomy as measured by CBCT(Baseline(without device),with device)
研究者
Aaron Glick
Clinical Assistant Professor
The University of Texas Health Science Center, Houston