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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy
• Intervention / Treatment: Other: 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.

• Study Type: Interventional
• Enrollment (Anticipated): 17
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yoav Gimmon, PhD; Phone Number: +972-50-6442243; Email: ygimmon@univ.haifa.ac.il
• Study Contact Backup: Name: Hadas Ben-Rubi Shimron, M.Sc.PT; Phone Number: +972-54-7780224; Email: hadas.vpt@gmail.com

Study Locations

• Israel
  • Haifa, Israel
    • Recruiting
    • University of Haifa
    • Contact: Yoav Gimmon, PhD; Phone Number: +972-50-6442243; Email: ygimmon@univ.haifa.ac.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Logarithm of the Minimum Angle of Resolution (logMAR)	Units measuring visual acuity	6am following normal sleep and 6am during sleep deprivation.

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 19, 2022
• Primary Completion (Anticipated): July 6, 2023
• Study Completion (Anticipated): July 6, 2023

Study Registration Dates

• First Submitted: April 30, 2023
• First Submitted That Met QC Criteria: April 30, 2023
• First Posted (Actual): May 9, 2023

Study Record Updates

• Last Update Posted (Actual): May 24, 2023
• Last Update Submitted That Met QC Criteria: May 23, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: VOR,vergence modulation,sleep deprivation,adaptation
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Dyssomnias; Sleep Wake Disorders; Neurologic Manifestations; Sleep Deprivation
• Other Study ID Numbers: 206/22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No