跳至主要内容
临床试验/NCT02695667
NCT02695667终止不适用

Quantitative Genioglossal Muscle Strength in Obstructive Sleep Apnea (OSAS) Defined in the Clinical Spectrum of Subjects With Snoring Disturbance, Oral Appliance Therapy Responsive, and CPAP Responsive.

University of New Mexico1 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2016年2月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
13
试验地点
1
主要终点
Genioglossal Strength

研究概览

简要总结

Quantitative Genioglossal muscle strength in Obstructive Sleep Apnea (OSAS) defined in the clinical spectrum of subjects with Snoring Disturbance, Oral Appliance Therapy Responsive, and CPAP Responsive

详细描述

To describe by statistical analysis the normal distribution domain of genioglossus muscle strength in each of the four clinical stages of Sleep Apnea; and, by regression analysis, to explore the possibility of an inverse relationship between decreasing genioglossus strength and progression of the clinical stages of OSAS.

1.3. To test the hypothesis that a "subpopulation of subject" exists within the clinical spectrum of OSAS, in whom decreasing strength of the genioglossus muscle may represent a common element in spite of differing possible pathophysiologic pathways leading to Obstructive Sleep Apnea in man. 1.4. The major hypothesis of this proposal is thus that "Genioglossal Strength is inversely correlated with Obstructive Sleep Apnea Pathology."

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age 20-40 years inclusive BMI 18-25 Non-smoking history and no current use for a minimum of 6 months No smokeless tobacco products (including e-cigarettes) for a minimum of 6 months No sleep snoring reported by subject and by bedroom "companion" Self-described as active/athletic (i.e. regular hikes, walks, jogging, running, active Sports, such as volleyball, soccer, etc.) Self-described as healthy, with no known disease or recent illness Self-completed Epworth Sleepiness Scale of <6 (Johns, MW, A new method for Measuring daytime sleepiness: the Epworth Sleepiness Scale; SLEEP 14:450-5, 1991). Physical Examination Mallampati Score of Class 1 (Nuckton, TJ, et al: Physical
  • Examination: Mallampati Score as an Independent Predictor of OSAS; SLEEP 29:
  • 903-908, 2006).

排除标准

  • 未提供

结局指标

主要结局

Genioglossal Strength

时间窗: single clinic visit

quantitative measurement of tongue strength

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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