NCT01069068已完成不适用
Assessment of the Impact of a Stepped Mouthpiece on the Upper Airways Measured Through Acoustic Pharyngometry
Doctor's Directive Strategies Inc.1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2010年2月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To measure the impact of different horizontal mandibular advancements, achieved through a stepped mouthpiece design, on the size of the upper airways in subjects with and without Obstructive Sleep Apnea (OSA).
研究概览
简要总结
Mandibular advancements during tidal breathing, achieved through a stepped mouthpiece design, affect the size of the upper airways in subjects with and without Obstructive Sleep Apnea.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects must provide written informed consent to participate in the study.
- •Adult male or female subjects over 18 years of age who have or have not been diagnosed with OSA.
- •Subjects claiming no history of OSA should take the Epworth questionnaire and obtain a result less than
- •Subjects must satisfy the study investigator about their fitness to participate in the study.
- •Subjects must be available to complete the study.
排除标准
- •Subjects not compliant with the instructions for use of the stepped mouthpiece and the study procedures.
- •Subjects who have participated in a clinical trial in the previous month.
结局指标
主要结局
To measure the impact of different horizontal mandibular advancements, achieved through a stepped mouthpiece design, on the size of the upper airways in subjects with and without Obstructive Sleep Apnea (OSA).
时间窗: one 60 minute session
次要结局
- Assessment of the habitual mandibular position in (edge-to-edge, millimetres) relation to the front upper teeth(one 60 minute session)
- Measurement of the upper airways through acoustic pharyngometry during slow and deep breathing while the subject uses a stepped mouthpiece. The acoustic pharyngometry measurement will be performed at mid inhalation(one 60 minute session)
- Assessment of the most comfortable position when using the stepped mouthpiece during both "tidal" and "slow and deep breathing". The scoring of the "comfortable position" will be performed through a Likert-style questionnaire(one 60 minute session)
- The most "comfortable position" established as outlined above will be evaluated for comfort while holding that position for 3 minutes. After the 3 minutes, the subject's level of comfort will be re-evaluated through a Likert-style questionnaire(one 60 minute session)
研究者
Dr John Viviano
Principal Investigator
Doctor's Directive Strategies Inc.
研究点 (1)
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