Motion SicknessNCT06128707
Vestibulo-Ocular Reflex Function in Individuals With Chronic Motion Sensitivity Cross-Sectional Study
An observational study of Motion Sickness, run by Loma Linda University at 1 site in United States.
Trial summary
Chronic motion sensitivity refers to a sensation of unwellness caused by physical or discerned motion and has a prevalence of 28% in the general population and it is more common in women (27.3%) compared to men. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Motion Sickness
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2023to 1 Feb 2024
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 20 to 40 years
- All sexes
- Adult
Study population: Participants will be recruited from Loma Linda University and surrounding communities. The study will be conducted in the Loma Linda University Physical Therapy Department's Neuroscience Research Laboratory. Participants between the age of 20 and 30 with and without a self-reported history of chronic motion sensitivity (i.e, experiencing nauseousness and/or dizziness during while using various means of transportation such as, car, train, bus, boat, and airplane and/or, recreational fun-fair rides and/or when exposed to conflicting visual images)
Who may be able to join
- Age 20-40
- With and without a history of CMS
Who cannot join
- CNS disorder
- Impaired cervical spine ROM
- Migraines
- Seizures
- Vestibular dysfunction
- Musculoskeletal dysfunction
- Medications causing dizziness
Trial locations and contacts
1 site in 1 country.
About this study
Chronic motion sensitivity refers to a sensation of unwellness caused by physical or discerned motion and has a prevalence of 28% in the general population and it is more common in women (27.3%) compared to men.
The investigators theorize that individuals with chronic motion sensitivity will have an impaired inner ear reflex and will be less physically active. Hence, the purpose of this study is to;
- Determine whether the function of an inner ear reflex is different between young adults with/without chronic motion sensitivity
- Assess relationships between reflex function and balance in young adults with/without CMS
- Assess relationships between physical activity and balance in young adults with/without CMS.
Read the detailed description
Chronic motion sensitivity (CMS), also known as motion sickness, refers to a sensation of unwellness caused by physical or discerned motion. CMS has a prevalence of 28% in the general population and it is more common in women (27.3%) compared to men.
Based on established evidence that individuals with chronic motion sensitivity demonstrate impaired postural stability with vestibular system impairment adjudged to be an inciting stimulus for chronic motion sensitivity, and individuals who practiced more physical and sporting activities have less motion sickness susceptibility than individuals who did not, the investigators theorize that individuals with chronic motion sensitivity will have an impaired inner ear reflex, causing them to be more reliant on other sensory systems like their muscles and joints, and their vision, we also theorize that individuals who are physically active will be less susceptible to chronic motion sensitivity.
The purpose of this study is to;
- Determine whether the function of an inner ear reflex is different between young adults with/without chronic motion sensitivity
- Assess relationships between reflex function and balance in young adults with/without CMS
- Assess relationships between physical activity and balance in young adults with/without CMS.
Participants between the age of 20 and 40 with and without a self-reported history of chronic motion sensitivity (i.e, experiencing nauseousness and/or dizziness during while using various means of transportation such as, car, train, bus, boat, and airplane and/or, recreational fun-fair rides and/or when exposed to conflicting visual images). Participants will be excluded if they report a medical diagnosis of central nervous system disorder, impaired cervical spine range of motion, migraines, seizure disorder, vestibular dysfunction, or any musculoskeletal dysfunction that can limit their participation in the study.
- Conditions
- Motion Sickness
- Keywords
- Chronic motion sensitivity
- Medical subject headings
- Motion Sickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Chronic Motion sensitivity group | Participants with a self-reported history of chronic motion sensitivity and who scored greater than or equal to the 30th percentile on the Motion sickness susceptibility questionnaire short form. | |
| Non-Chronic Motion sensitivity Group | Participants without a self-reported history of chronic motion sensitivity and who scored less than or equal to the 25th percentile on the Motion sickness susceptibility questionnaire short form. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bertec vision advantage
Scores on 4 parametters- Baseline visual acuity (Logarithm of the minimum angle of resolution LogMAR)- A measure of optotype size with lower values signifying smaller optotype size and better vision with the head static, Visual processing time (Mili seconds) this is the time taken to identify the size of the optotype, Dynamic visual acuity (Logarithm of the minimum angle of resolution LogMAR)-A measure of optotype size with lower values signifying smaller optotype size and better vision with the head dynamic, Gaze stability test (Degrees per second), this is the highest speed at which the participant can identify the optotype while the head is moving.
Measured: 1 day
Computerized dynamic posturography with immersion virtual reality
Average scores under 2 conditions- Condition one- Eye open, Stable platform, Condition 2 Eye open, sway referenced platform. Each condition measured gives a score known as the equillibrum score measured as age matched normative data with higher scores signifying stronger balance , and a lower scores signifying weaker balance
Measured: 1 day
Secondary outcomes (1)
International Physical activity questionaire short form
Questionaire to assess physical activity
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start30 Sep 2023
- Primary completion1 Feb 2024
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Motion SicknessStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 59 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06128707
- Sponsor's protocol ID
- IRB# 5230167
- Status last verified
- Oct 2024
- First submitted
- 25 Oct 2023
- Last updated
- 26 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vestibulo-Ocular Reflex Function in Individuals With Chronic Motion Sensitivity Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT06128707
- Acronym / sponsor ID
- IRB# 5230167
- Conditions
- Motion Sickness
- Keywords
- Chronic motion sensitivity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- 30 Sep 2023 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 13 Nov 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.
Chronic motion sensitivity refers to a sensation of unwellness caused by physical or discerned motion and has a prevalence of 28% in the general population and it is more common in women (27.3%) compared to men.
The investigators theorize that individuals with chronic motion sensitivity will have an impaired inner ear reflex and will be less physically active. Hence, the purpose of this study is to;
- Determine whether the function of an inner ear reflex is different between young adults with/without chronic motion sensitivity
- Assess relationships between reflex function and balance in young adults with/without CMS
- Assess relationships between physical activity and balance in young adults with/without CMS.
Detailed description
Chronic motion sensitivity (CMS), also known as motion sickness, refers to a sensation of unwellness caused by physical or discerned motion. CMS has a prevalence of 28% in the general population and it is more common in women (27.3%) compared to men.
Based on established evidence that individuals with chronic motion sensitivity demonstrate impaired postural stability with vestibular system impairment adjudged to be an inciting stimulus for chronic motion sensitivity, and individuals who practiced more physical and sporting activities have less motion sickness susceptibility than individuals who did not, the investigators theorize that individuals with chronic motion sensitivity will have an impaired inner ear reflex, causing them to be more reliant on other sensory systems like their muscles and joints, and their vision, we also theorize that individuals who are physically active will be less susceptible to chronic motion sensitivity.
The purpose of this study is to;
- Determine whether the function of an inner ear reflex is different between young adults with/without chronic motion sensitivity
- Assess relationships between reflex function and balance in young adults with/without CMS
- Assess relationships between physical activity and balance in young adults with/without CMS.
Participants between the age of 20 and 40 with and without a self-reported history of chronic motion sensitivity (i.e, experiencing nauseousness and/or dizziness during while using various means of transportation such as, car, train, bus, boat, and airplane and/or, recreational fun-fair rides and/or when exposed to conflicting visual images). Participants will be excluded if they report a medical diagnosis of central nervous system disorder, impaired cervical spine range of motion, migraines, seizure disorder, vestibular dysfunction, or any musculoskeletal dysfunction that can limit their participation in the study.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic Motion sensitivity group | – | –Participants with a self-reported history of chronic motion sensitivity and who scored greater than or equal to the 30th percentile on the Motion sickness susceptibility questionnaire short form. |
| Non-Chronic Motion sensitivity Group | – | –Participants without a self-reported history of chronic motion sensitivity and who scored less than or equal to the 25th percentile on the Motion sickness susceptibility questionnaire short form. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Age groups
- Adult
- Study population
- Participants will be recruited from Loma Linda University and surrounding communities. The study will be conducted in the Loma Linda University Physical Therapy Department's Neuroscience Research Laboratory. Participants between the age of 20 and 30 with and without a self-reported history of chronic motion sensitivity (i.e, experiencing nauseousness and/or dizziness during while using various means of transportation such as, car, train, bus, boat, and airplane and/or, recreational fun-fair rides and/or when exposed to conflicting visual images)
Key inclusion criteria (2 listed)
- Age 20-40
- With and without a history of CMS
Key exclusion criteria (7 listed)
- CNS disorder
- Impaired cervical spine ROM
- Migraines
- Seizures
- Vestibular dysfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Bertec vision advantage
Time frame: 1 day
Scores on 4 parametters- Baseline visual acuity (Logarithm of the minimum angle of resolution LogMAR)- A measure of optotype size with lower values signifying smaller optotype size and better vision with the head static, Visual processing time (Mili seconds) this is the time taken to identify the size of the optotype, Dynamic visual acuity (Logarithm of the minimum angle of resolution LogMAR)-A measure of optotype size with lower values signifying smaller optotype size and better vision with the head dynamic, Gaze stability test (Degrees per second), this is the highest speed at which the participant can identify the optotype while the head is moving.
Computerized dynamic posturography with immersion virtual reality
Time frame: 1 day
Average scores under 2 conditions- Condition one- Eye open, Stable platform, Condition 2 Eye open, sway referenced platform. Each condition measured gives a score known as the equillibrum score measured as age matched normative data with higher scores signifying stronger balance , and a lower scores signifying weaker balance
1 secondary outcome
International Physical activity questionaire short form
Time frame: 1 day
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 26 Oct 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Motion Sickness, run by Loma Linda University at 1 site in United States.
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 2 inclusion and 7 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 26 Oct 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 United States. 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?
Bertec vision advantage (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Oct 2024.