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

NCT ID: NCT05850767

Last Updated: 2024-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-19
• Study Completion Date: 2023-07-06

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.

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Sleep deprivation

Participants will stay fully awake for 24 hours.

Group Type: EXPERIMENTAL

Sleep deprivation

Intervention Type: OTHER

Participants will stay fully awake for 24 hours

Normal sleep

Participant will sleep a normal night sleep.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Sleep deprivation

Participants will stay fully awake for 24 hours

Intervention Type: OTHER

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)

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Yoav Gimon

OTHER

Sponsor Role: lead

Responsible Party

Yoav Gimon

Senior lecturer

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Yoav Gimmon, Phd

Role: PRINCIPAL_INVESTIGATOR

University of Haifa, Haifa, Israel

Locations

University of Haifa

Haifa, , Israel

Countries

Israel

References

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.

Reference Type: BACKGROUND

PMID: 33065632 (View on PubMed)

Other Identifiers

206/22

Identifier Type: -

Identifier Source: org_study_id