HealthyNCT05850767
The Effect of Sleep Deprivation on Passive and Active Functions and Distance Modulation of the Vestibulo-Ocular Reflex
A study testing Sleep deprivation in people with Healthy, run by Yoav Gimon at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Sleep deprivation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteIsrael
- Study dates
- 19 May 2022to 6 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
- 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.
Read the 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
- Being tested
- Sleep deprivation
- Keywords
- VOR,vergence modulation,sleep deprivation,adaptation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep deprivationOther
Participants will stay fully awake for 24 hours
| Study group | Role | What they receive |
|---|---|---|
| Sleep deprivation | Experimental | Participants will stay fully awake for 24 hours. Receives: Other: Sleep deprivation |
| Normal sleep | No intervention | Participant will sleep a normal night sleep. |
What is being measured
The primary outcome is the main question the study is designed to answer.
VOR gain
The calculated ratio between eye velocity and head velocity during brief head movements
Measured: 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)
Units measuring visual acuity
Measured: 6am following normal sleep and 6am during sleep deprivation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2023
- Study start19 May 2022
- Primary completion6 Jul 2023
- Study completion6 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yoav Gimon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yoav Gimon, University of Haifa
- Investigators
- Yoav Gimmon, Phd, Principal investigator, University of Haifa, Haifa, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05850767
- Sponsor's protocol ID
- 206/22
- Status last verified
- May 2024
- First submitted
- 30 Apr 2023
- Last updated
- 13 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
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.
PubMed 33065632
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sleep Deprivation on Passive Function, Active Function and Distance Modulation of the Vestibulo-Ocular Reflex
- ClinicalTrials.gov ID
- NCT05850767
- Acronym / sponsor ID
- 206/22
- Conditions
- Healthy
- Keywords
- VOR,vergence modulation,sleep deprivation,adaptation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Yoav GimonUniversity, hospital or other
- Study start
- 19 May 2022 (actual)
- Primary completion
- 6 Jul 2023 (actual)
- Study completion
- 6 Jul 2023 (actual)
- First posted
- 9 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sleep deprivation | Experimental | Other: Sleep deprivationParticipants will stay fully awake for 24 hours. |
| Normal sleep | No intervention | –Participant will sleep a normal night sleep. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep deprivationParticipants will stay fully awake for 24 hours | Other | Sleep deprivation |
Primary outcome
VOR gain
Time frame: 9pm before and 6am after normal sleep. 9pm, 2am and 6am during sleep deprivation.
The calculated ratio between eye velocity and head velocity during brief head movements
1 secondary outcome
Logarithm of the Minimum Angle of Resolution (logMAR)
Time frame: 6am following normal sleep and 6am during sleep deprivation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2024.
- Background: PubMed 33065632Chang 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yoav Gimmon, Phd principal investigator
University of Haifa, Haifa, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep deprivation in people with Healthy, run by Yoav Gimon at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VOR gain (time frame: 9pm before and 6am after normal sleep. 9pm, 2am and 6am during sleep deprivation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05850767, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2024.