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

Sponsor
Yoav Gimon (Other)
Overall Status
Recruiting
CT.gov ID
NCT05850767
Collaborator
(none)
17
1
2
12.6
1.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Sleep deprivation
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
17 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
The Effect of Sleep Deprivation on Passive Function, Active Function and Distance Modulation of the Vestibulo-Ocular Reflex
Actual Study Start Date :
May 19, 2022
Anticipated Primary Completion Date :
May 6, 2023
Anticipated Study Completion Date :
Jun 6, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Sleep deprivation

Participants will stay fully awake for 24 hours.

Other: Sleep deprivation
Participants will stay fully awake for 24 hours

No Intervention: Normal sleep

Participant will sleep a normal night sleep.

Outcome Measures

Primary Outcome Measures

  1. VOR gain [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 Outcome Measures

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

    Units measuring visual acuity

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

Age 30-60 years old, healthy, persons who are not night shift workers, that 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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Haifa Haifa Israel

Sponsors and Collaborators

  • Yoav Gimon

Investigators

  • Principal Investigator: Yoav Gimmon, Phd, University of Haifa, Haifa, Israel

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Yoav Gimon, Senior lecturer, University of Haifa
ClinicalTrials.gov Identifier:
NCT05850767
Other Study ID Numbers:
  • 206/22
First Posted:
May 9, 2023
Last Update Posted:
May 9, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Yoav Gimon, Senior lecturer, University of Haifa
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 9, 2023