The Effect of Sleep Deprivation on Passive and Active Functions and Distance Modulation of the Vestibulo-Ocular Reflex
Primary Purpose
Healthy
Status
Recruiting
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Sleep deprivation
Sponsored by
About this trial
This is an interventional basic science trial for Healthy focused on measuring VOR,vergence modulation,sleep deprivation,adaptation
Eligibility Criteria
Inclusion Criteria: 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 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)
Sites / Locations
- University of HaifaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Sleep deprivation
Normal sleep
Arm Description
Participants will stay fully awake for 24 hours.
Participant will sleep a normal night sleep.
Outcomes
Primary Outcome Measures
VOR gain
The calculated ratio between eye velocity and head velocity during brief head movements
Secondary Outcome Measures
Logarithm of the Minimum Angle of Resolution (logMAR)
Units measuring visual acuity
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05850767
Brief Title
The Effect of Sleep Deprivation on Passive and Active Functions and Distance Modulation of the Vestibulo-Ocular Reflex
Official Title
The Effect of Sleep Deprivation on Passive Function, Active Function and Distance Modulation of the Vestibulo-Ocular Reflex
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 19, 2022 (Actual)
Primary Completion Date
July 6, 2023 (Anticipated)
Study Completion Date
July 6, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yoav Gimon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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:
The effect of sleep deprivation on vestibular function.
The difference between passive and active VOR function following sleep deprivation.
The vergence mediated modulation ability of the VOR following sleep deprivation.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy
Keywords
VOR,vergence modulation,sleep deprivation,adaptation
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
17 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sleep deprivation
Arm Type
Experimental
Arm Description
Participants will stay fully awake for 24 hours.
Arm Title
Normal sleep
Arm Type
No Intervention
Arm Description
Participant will sleep a normal night sleep.
Intervention Type
Other
Intervention Name(s)
Sleep deprivation
Intervention Description
Participants will stay fully awake for 24 hours
Primary Outcome Measure Information:
Title
VOR gain
Description
The calculated ratio between eye velocity and head velocity during brief head movements
Time Frame
9pm before and 6am after normal sleep. 9pm, 2am and 6am during sleep deprivation.
Secondary Outcome Measure Information:
Title
Logarithm of the Minimum Angle of Resolution (logMAR)
Description
Units measuring visual acuity
Time Frame
6am following normal sleep and 6am during sleep deprivation.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yoav Gimmon, Phd
Phone
+972-50-6442243
Email
ygimmon@univ.haifa.ac.il
First Name & Middle Initial & Last Name or Official Title & Degree
Hadas Ben-Rubi Shimron, M.Sc.PT
Phone
+972-54-7780224
Email
hadas.vpt@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yoav Gimmon, Phd
Organizational Affiliation
University of Haifa, Haifa, Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Haifa
City
Haifa
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yoav Gimmon, PhD
Phone
+972-50-6442243
Email
ygimmon@univ.haifa.ac.il
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
PubMed Identifier
33065632
Citation
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.
Results Reference
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The Effect of Sleep Deprivation on Passive and Active Functions and Distance Modulation of the Vestibulo-Ocular Reflex
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