The Effect of Sleep Deprivation on Passive and Active Functions and Distance Modulation of the Vestibulo-Ocular Reflex
1 other identifier
interventional
17
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable healthy
Started May 2022
Typical duration for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 19, 2022
CompletedFirst Submitted
Initial submission to the registry
April 30, 2023
CompletedFirst Posted
Study publicly available on registry
May 9, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 6, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 6, 2023
CompletedMay 13, 2024
May 1, 2024
1.1 years
April 30, 2023
May 10, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
VOR gain
The calculated ratio between eye velocity and head velocity during brief head movements
9pm before and 6am after normal sleep. 9pm, 2am and 6am during sleep deprivation.
Secondary Outcomes (1)
Logarithm of the Minimum Angle of Resolution (logMAR)
6am following normal sleep and 6am during sleep deprivation.
Study Arms (2)
Sleep deprivation
EXPERIMENTALParticipants will stay fully awake for 24 hours.
Normal sleep
NO INTERVENTIONParticipant will sleep a normal night sleep.
Interventions
Eligibility Criteria
You may qualify if:
- Age 30-60 years old
- Healthy
- Persons who are not night shift workers
- Persons who are not used to but can keep awake for 24 hours
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yoav Gimonlead
Study Sites (1)
University of Haifa
Haifa, Israel
Related Publications (1)
Chang TP, Schubert MC. Convergence Vestibulo-ocular Reflex in Unilateral Vestibular Hypofunction: Behavioral Evidence in Support of a Novel Gaze Stability Exercise. J Neurol Phys Ther. 2021 Jan;45(1):3-11. doi: 10.1097/NPT.0000000000000335.
PMID: 33065632BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
Yoav Gimmon, Phd
University of Haifa, Haifa, Israel
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Senior lecturer
Study Record Dates
First Submitted
April 30, 2023
First Posted
May 9, 2023
Study Start
May 19, 2022
Primary Completion
July 6, 2023
Study Completion
July 6, 2023
Last Updated
May 13, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR