Improvement of Mouth Breathing Habits During Sleep in Patients With Obstructive Sleep Apnea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Differences in percentage of mouth puffing before and after the six weeks oral device intervention
研究概览
简要总结
This study intends to investigate the improvement in patients with OSA through objective measurement, including oxygen desaturation index (ODI) and the percentage reduction in intermittent mouth puffing (IMP) before and after the intervention. The oral appliances are placed between the tongue and the soft palate to reduce the oral ventilation space. A total of 24 participants aged between 36 and 57 years were identified with ODI above 5 events/hour by measuring their blood oxygen and with an originally designed mouth puffing detector to find out those who were still mouth-puffed when their mouths were taped. A suitable appliance was chosen for the participants between the two originally designed oral appliances, tongue pressed device (TPD) and tongue elevated device (TED), and the intervention lasted for six weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) aged 20-60 years old,
- •(2) having symptoms of OSA including snoring, daytime sleepiness, etc.
- •(3) AHI & ODI >=5 events/hour,
排除标准
- •(1) taken sleep medication within the last two months or were on long-term use,
- •(2) reported tobacco, alcohol, caffeine or drug addiction,
- •(3) cancer, cardiovascular disease, psychiatric illness, kidney disease, diabetes mellitus, or other sleep disorders.
结局指标
主要结局
Differences in percentage of mouth puffing before and after the six weeks oral device intervention
时间窗: baseline, six weeks after intervention
According to the number of mouth puffing by minutes, mouth puffing signals were divided into four types, including non-mouth puffing (NMP, no or less than 3 times MPSs on both sides), complete mouth puffing (CMP, regularly MPS on both sides, usually above 8-10 times), intermittent mouth puffing (IMP, irregularly MPS in both side, usually between 3-8 times), and side mouth puffing (SMP, showing one-side MPSs) to evaluate the percentage of mouth breathing while sleeping.
Differences in OSA-related variables before and after the six weeks oral device intervention
时间窗: baseline, six weeks after intervention
According to OSA-related variables, we can analyze participants' ODI (events/hours), mean SpO2 (%), the lowest SpO2(%), and the percentage of total record time with oxygen saturation below 90% (T90) to evaluate their objective sleep quality.
次要结局
未报告次要终点