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临床试验/NCT05850767
NCT05850767已完成不适用

The Effect of Sleep Deprivation on Passive Function, Active Function and Distance Modulation of the Vestibulo-Ocular Reflex

Yoav Gimon1 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2022年5月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Yoav Gimon
入组人数
17
试验地点
1
主要终点
VOR gain

研究概览

简要总结

The goal of this cross-over clinical trial is to evaluate the effect of 24 hours sleep deprivation on the Vestibulo-Ocular Reflex (VOR) in healthy participants.

The main questions it aims to answer are:

  1. The effect of sleep deprivation on vestibular function.
  2. The difference between passive and active VOR function following sleep deprivation.
  3. The vergence mediated modulation ability of the VOR following sleep deprivation.
  4. The effect of sleep deprivation on behavioral VOR function.

Participants will be tested before and after a normal night sleep and during 24 hours of sleep deprivation.

详细描述

The study will include two sleep protocols: Normal sleep and 24h sleep deprivation. The participants will be informed and will sign a consent form. Participants will then be randomly divided to begin with one of the sleep protocols. To avoid major changes in participants lifestyle, that might intervene with the basic measurements, both nights will take place within a maximum of one month and a minimum of one week for recovery between them. One week prior to each condition, participants will fill a sleep diary which will include their sleep duration to ensure that a routine sleep pattern will be maintained prior to each of the tests. Participants will be instructed not to consume alcoholic drinks or mind-altering substances for 24h prior, and during both conditions, and caffeine for 12h prior and during both conditions.

To enable normal sleep as possible, the normal sleep protocol will take place in each of the participants home. Matching environmental conditions will be kept to those of the clinic (lighting, white background) where the sleep deprivation protocol will be held. The participants will be tested using the Video Head Impulse test (vHIT) and the Computerized Dynamic Visual Acuity test (c-DVA) during both nights. The participants will be equipped with an ActiGraph watch wGT3X-BT to assure sleeping conditions.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
None

入排标准

年龄范围
30 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age 30-60 years old
  • Persons who are not night shift workers
  • Persons who are not used to but can keep awake for 24 hours

排除标准

  • Night shift workers
  • Vestibular system deficiency in vHIT test
  • Active neurological disease
  • Any orthopedic deficit in the cervical area preventing a proper vHIT examination
  • A diagnosed sleep disorder or >5 score in the Pittsburgh sleep quality questionnaire Hebrew version (PSQI)

结局指标

主要结局

VOR gain

时间窗: 9pm before and 6am after normal sleep. 9pm, 2am and 6am during sleep deprivation.

The calculated ratio between eye velocity and head velocity during brief head movements

次要结局

  • Logarithm of the Minimum Angle of Resolution (logMAR)(6am following normal sleep and 6am during sleep deprivation.)

研究者

发起方
Yoav Gimon
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Yoav Gimon

Senior lecturer

University of Haifa

研究点 (1)

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