The Efficacy of Tongue Stabilizing Device in Patients With Obstructive Sleep Apnea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Apnea-hypopnea index
研究概览
简要总结
The coordination of swallowing and breathing is an important mechanism because the route for air and deglutition is partly shared in the pharynx. Tongue Stabilizing Device (TSD) is a preformed appliance for Obstructive Sleep Apnea (OSA) that protrudes the tongue and improves upper airway structure and function during sleep. Investigators will attempt to assess efficacy of TSD therapy on OSA and the physiological change of swallowing and breathing routes in OSA patients during sleep.
详细描述
Purpose:
The purpose of this study is to determine the efficacy of TSD and to assess if it alters swallowing frequency and breathing modes in OSA patients during sleep.
Hypothesis:
Investigators hypothesize that TSD therapy will improve OSA symptoms and will lead to effective nasal breathing which may decrease swallowing frequency in OSA patients during sleep.
Justification:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Patients included in this study must:
- •be 18 years of age or older
- •have an objective diagnosis of mild to moderate obstructive sleep apnea (OSA) [5 ≤ AHI ≤ 50]; and
- •have a Body Mass Index (BMI) ≤ 35
排除标准
- •Patients are excluded in this study who:
- •have had previous surgery of the soft palate;
- •have neuromuscular disease;
- •are taking medications which disturb sleep; and/or
- •have ≤ 90% oxygen saturation levels for 20% of the night.
研究组 & 干预措施
Tongue Stabilizing Device Treatment
Tongue Stabilizing Device (TSD) is a preformed appliance for OSA that protrudes the tongue and improves upper airway structure and function during sleep.
干预措施: Tongue Stabilizing Device (TSD) (Device)
结局指标
主要结局
Apnea-hypopnea index
时间窗: At 2-6 months of TSD treatment follow up
Measuring changes in apnea-hypopnea index (events/hour) to compare baseline and 2-6 months of TSD treatment follow up.
Frequency of swallowing
时间窗: At 2-6 months of TSD treatment follow up
Measuring changes in frequency of swallowing (events/hour) to compare baseline and 2-6 months of TSD treatment follow up.
Apnea-hypopnea index
时间窗: At baseline
Measuring apnea-hypopnea index (events/hour) to measure intervention efficacy (e.g. AHI)
Frequency of swallowing
时间窗: At baseline
Measuring frequency of swallowing (events/hour) to assess influence by intervention
次要结局
- Functional Outcomes of Sleep Questionnaire (FOSQ) responses(At 2-6 months of TSD treatment follow up)
- VR-36 survey responses(At 2-6 months of TSD treatment follow up)
- Compliance (Measuring adherence (hours/nights and nights/week of intervention use))(At 2-6 months of TSD treatment follow up)
- Epworth Sleepiness Scale (ESS) questionnaire responses.(At 2-6 months of TSD treatment follow up)
- Breathing route(At 2-6 months of TSD treatment follow up)
- Swallowing apnea time(At 2-6 months of TSD treatment follow up)
- Functional Outcomes of Sleep Questionnaire (FOSQ) responses(At baseline)
- Epworth Sleepiness Scale (ESS) questionnaire responses.(At baseline)
- VR-36 survey responses(At baseline)
- Breathing route(At baseline)
- Swallowing apnea time(At baseline)
研究者
Fernanda Almeida
Principle Investigator
University of British Columbia