The Effect of Sleep Deprivation on Passive and Active Fun... | NCT05850767

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

NCT05850767

Sponsor

Yoav Gimon

Status

Completed

Last Update Posted

May 13, 2024Actual

Enrollment

17Actual

Phase

Not Applicable

Conditions

Healthy

Interventions

Sleep deprivation

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 19, 2022Actual

Primary Completion Date

Jul 6, 2023Actual

Completion Date

Jul 6, 2023Actual

First Submitted Date

Apr 30, 2023

First Submission Date that Met QC Criteria

Apr 30, 2023

First Posted Date

May 9, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 10, 2024

Last Update Posted Date

May 13, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

17Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sleep deprivation	Experimental	Participants will stay fully awake for 24 hours.	Other: Sleep deprivation
Normal sleep	No Intervention	Participant will sleep a normal night sleep.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sleep deprivation	Other	Participants will stay fully awake for 24 hours	Sleep deprivation

Outcomes Module

Primary Outcomes

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 Outcomes

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.

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yoav Gimmon, Phd	University of Haifa, Haifa, Israel	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Haifa		Haifa			Israel

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33065632	Background	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.