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Clinical Trials/NCT05850767
NCT05850767
Completed
Not Applicable

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

Yoav Gimon1 site in 1 country17 target enrollmentMay 19, 2022
ConditionsHealthy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Healthy
Sponsor
Yoav Gimon
Enrollment
17
Locations
1
Primary Endpoint
VOR gain
Status
Completed
Last Updated
last year

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
May 19, 2022
End Date
July 6, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Yoav Gimon
Responsible Party
Sponsor Investigator
Principal Investigator

Yoav Gimon

Senior lecturer

University of Haifa

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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)

Outcomes

Primary Outcomes

VOR gain

Time Frame: 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

Secondary Outcomes

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

Study Sites (1)

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