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临床试验/NCT01491828
NCT01491828已完成1 期

Study to Determine Results of Vibratory Stimulus on Subject's Neck

Kai Medical, Inc.1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2011年11月1日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
100
试验地点
1
主要终点
Head, neck, or jaw movement

研究概览

简要总结

This study will validate whether an external vibratory stimulus applied to a subject's neck causes head, neck or jaw movement.

详细描述

This study will validate whether an external vibratory stimulus applied to a subject's neck causes head, neck or jaw movement, and provide information regarding the optimum location and variable vibration parameters of vibratory stimulus on a subject's neck to cause head, neck, or jaw movement. The study will also provide information whether the subject experienced or did not experience a change in sleep stage or arousal by vibratory stimulus on a subject's neck. The data gathered from this study will be used for future studies in analyzing whether such vibratory stimulus can serve as a potential treatment for sleep disorders, such as snoring and obstructive sleep apnea.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Male or female, ages 18 to 80 years old
  • •Able to provide written informed consent for themselves and comply with study procedures.

排除标准

  • •Known hyposensitivity or hypersensitivity to vibrations on neck.
  • •Neurological disorder such as seizure disorder or narcolepsy.
  • •Psychiatric disorders currently not under control.
  • •Insomniacs.
  • •Pregnant women.

结局指标

主要结局

Head, neck, or jaw movement

时间窗: 1 month

Movement of head, neck, or jaw as evidenced by manual observation and video camera.

次要结局

  • Affect of sleep stage(1 month)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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