The Heterogeneous Effects of Mouth Closure on Airflow in Patients With Obstructive Sleep Apnea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Total inspiratory flow
研究概览
简要总结
Mouth breathing is associated with increased airway resistance, pharyngeal collapsibility, and obstructive sleep apnea (OSA) severity. It is commonly believed that closing the mouth can mitigate the negative effects of mouth breathing during sleep. However, the investigators propose that mouth breathing serves as an essential route bypassing obstruction along the nasal route (e.g., velopharynx). The present study investigates the role of mouth breathing as an essential route in some OSA patients and its association with upper airway anatomical factors.
Participants underwent drug-induced sleep endoscopy (DISE) with simultaneous pneumotach airflow measurements through the nose and mouth separately. During the DISE procedure, alternating mouth closure (every other breath) cycles were performed during flow-limited breathing.
The investigators evaluated the overall effect mouth closure on inspiratory airflow, and the change in inspiratory airflow with mouth closure across three mouth-breathing quantiles. The investigators also evaluated if velopharyngeal obstruction was associated with mouth breathing and a negative airflow response to mouth closure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed obstructive sleep apnea (AHI > 5 events/h).
- •Scheduled to undergo clinical drug-induced sleep endoscopy.
排除标准
- •pregnancy
- •age under 18 years
- •poor general health
- •allergy to propofol or dexmedetomidine
- •history of surgical treatment for sleep apnea, such as palate, tongue base, or epiglottis surgery.
研究组 & 干预措施
Mouth relaxed
Mouth in the natural relaxed position during sleep.
Mouth closed
Closing the mouth by applying pressure to the mentum until the teeth were in occlusion, without altering the head position. Performed during flow-limited breathing.
干预措施: Mouth closure (Other)
结局指标
主要结局
Total inspiratory flow
时间窗: 1 day - the intervention of mouth closure on the outcome is applied acutely on alternating breaths, such that the effect of mouth closure is assessed based on the experiment which occurs in a single day.
Change in airflow in the transition from mouth relaxed to mouth closed (intervention).
次要结局
- Change in total inspiratory airflow with mouth closure(1 day - the intervention of mouth closure is applied acutely on alternating breaths, such that the effect of mouth closure on the outcome is assessed based on the experiment which occurs in a single day.)
研究者
David Andrew Wellman
Professor
Brigham and Women's Hospital