Vestibular Function TestsNCT04788134
Post- Rotatory Nystagmus Test: Normative Data for Spanish Adolescents and Adults
An observational study of Vestibular Function Tests and Nystagmus Vestibular, run by Quesada, Rocío Vico.
Trial summary
The vestibulo-ocular reflex is the motor response of our eyes in the opposite direction to a translational or rotational movement of our head. The post-rotational nystagmus test (PRN) assesses the integrity of this reflex, thus assessing the perception of the vestibular system. Read more about this study
- Who is it for?
- Ages 13 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vestibular Function Tests, Nystagmus Vestibular
- What is being tested?
- Post-rotatory nystagmus test
- How many people
- 163 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2021to 1 Sep 2021
- 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 13 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: People over 13 years, that lives in the north, middle and south of Spain, and meet the selection criteria.
Who may be able to join
- People over 13 years of age.
- Spanish-speaking population.
- Signature of the informed consent.
Who cannot join
- Diagnosis of a neurodevelopmental or neurological disorder.
- Being in occupational therapeutic treatment for balance or vestibular problems.
- Practice of sports in one previous hour.
- Adverse reaction to vestibular input such as vomiting, discoloration, feeling of unpleasantness or any other type of negative reaction before / during / after the administration of the NPR.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Normative Data for Post-rotatory Nystagmus Test at Spanish Adolescent and Adult Population: a Transversal Study
The vestibulo-ocular reflex is the motor response of our eyes in the opposite direction to a translational or rotational movement of our head. The post-rotational nystagmus test (PRN) assesses the integrity of this reflex, thus assessing the perception of the vestibular system. The duration of this reflex after administering this test has been widely studied in children from 2 months to 12 years and 11 months of age. However, there is a knowledge gap from that age that the present study seeks to address.
Read the detailed description
The vestibulo-ocular reflex (VOR) is the motor response of our eyes in the opposite direction to a translational or rotational movement of our head. The post-rotational nystagmus test (PRN) assesses the integrity of this reflex, thus assessing the perception of the vestibular system. This system has an important role in our balance, stabilization of the visual field when our head moves, awareness of the position of our head in space, postural control and functions of the Autonomous Nervous System.
The duration of this reflex after administering this test has been widely studied in children from 2 months to 12 years and 11 months of age. However, there is a knowledge gap from that age that the present study seeks to address. This article aims to explore the use of the PRN test for adolescent and adults, to prove if the duration of the VOR is longer in these population than in children. It will be also recollected personal data to study whether exposure to vestibular input influences its reactivity and perception.
- Conditions
- Vestibular Function Tests, Nystagmus Vestibular
- Being tested
- Post-rotatory nystagmus test
- Keywords
- vestibular function tests, nystagmus, physiologic, adult, adolescent
- Medical subject headings
- Nystagmus, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Post-rotatory nystagmus testDiagnostic test
The test is administrated with the person sit down with cross legs at a rotatory board, with the head positioned by the examiner in 30° of forward flexion. The position was maintained by the administration of the test. The administration consist in two administrations separate by one minute. Each administration consist in rotate the person 10 times in 20 seconds (the first 10 rotations in a counterclockwise direction in 20 s and the second 10 rotations in a clockwise direction in 20 s). After each administration the examiner counts the duration of the reflex in seconds.
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of vestibular-ocular reflex after the administration of nystagmus post-rotatory test in adolescent and adult population
The post rotatory nystagmus test evaluates the duration of the vestibular-ocular reflex: how long its lats gives information about the perception of vestibular system. This reflex reflects the role of the vestibular system in ocular mechanisms (Mailloux et al., 2014). It is administered twice: clockwise and counterclockwise.After the administration the physiologic nystagmus appears, it is our vestibular-ocular reflex, and the examiner has to register the duration of it.
Measured: End of the nystagmus post rotatory test and end of the vestibular-ocular reflex
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2021
- Study start1 Apr 2021 (estimated)
- Primary completion1 Jun 2021 (estimated)
- Study completion1 Sep 2021 (estimated)
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 Vestibular Function TestsStudies 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
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 163 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Quesada, Rocío Vico
- Responsible party
- Principal investigator, Rocío Vico Quesada, Quesada, Rocío Vico
- Investigators
- Vico Rocío, Principal investigator, Quesada, Rocío VicoPedrero Yolanda, Principal investigator, Quesada, Rocío VicoZisa Nerina, Principal investigator, Quesada, Rocío Vico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04788134
- Sponsor's protocol ID
- 010395
- Status last verified
- Mar 2021
- First submitted
- 4 Mar 2021
- Last updated
- 9 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mailloux Z, Leao M, Becerra TA, Mori AB, Soechting E, Roley SS, Buss N, Cermak SA. Modification of the postrotary nystagmus test for evaluating young children. Am J Occup Ther. 2014 Sep-Oct;68(5):514-21. doi: 10.5014/ajot.2014.011031.
PubMed 25184463
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Normative Data for Post-rotatory Nystagmus Test at Spanish Adolescent and Adult Population: a Transversal Study
- ClinicalTrials.gov ID
- NCT04788134
- Acronym / sponsor ID
- 010395
- Conditions
- Vestibular Function Tests, Nystagmus Vestibular
- Keywords
- vestibular function tests, nystagmus, physiologic, adult, adolescent
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 163 participants (estimated)
- Lead sponsor
- Quesada, Rocío Vico
- Study start
- 1 Apr 2021 (estimated)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 1 Sep 2021 (estimated)
- First posted
- 9 Mar 2021 (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 vestibulo-ocular reflex is the motor response of our eyes in the opposite direction to a translational or rotational movement of our head. The post-rotational nystagmus test (PRN) assesses the integrity of this reflex, thus assessing the perception of the vestibular system. The duration of this reflex after administering this test has been widely studied in children from 2 months to 12 years and 11 months of age. However, there is a knowledge gap from that age that the present study seeks to address.
Detailed description
The vestibulo-ocular reflex (VOR) is the motor response of our eyes in the opposite direction to a translational or rotational movement of our head. The post-rotational nystagmus test (PRN) assesses the integrity of this reflex, thus assessing the perception of the vestibular system. This system has an important role in our balance, stabilization of the visual field when our head moves, awareness of the position of our head in space, postural control and functions of the Autonomous Nervous System.
The duration of this reflex after administering this test has been widely studied in children from 2 months to 12 years and 11 months of age. However, there is a knowledge gap from that age that the present study seeks to address. This article aims to explore the use of the PRN test for adolescent and adults, to prove if the duration of the VOR is longer in these population than in children. It will be also recollected personal data to study whether exposure to vestibular input influences its reactivity and perception.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- People over 13 years, that lives in the north, middle and south of Spain, and meet the selection criteria.
Key inclusion criteria (3 listed)
- People over 13 years of age.
- Spanish-speaking population.
- Signature of the informed consent.
Key exclusion criteria (4 listed)
- Diagnosis of a neurodevelopmental or neurological disorder.
- Being in occupational therapeutic treatment for balance or vestibular problems.
- Practice of sports in one previous hour.
- Adverse reaction to vestibular input such as vomiting, discoloration, feeling of unpleasantness or any other type of negative reaction before / during / after the administration of the NPR.
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 |
|---|---|---|
| Post-rotatory nystagmus testThe test is administrated with the person sit down with cross legs at a rotatory board, with the head positioned by the examiner in 30° of forward flexion. The position was maintained by the administration of the test. The administration consist in two administrations separate by one minute. Each administration consist in rotate the person 10 times in 20 seconds (the first 10 rotations in a counterclockwise direction in 20 s and the second 10 rotations in a clockwise direction in 20 s). After each administration the examiner counts the duration of the reflex in seconds. | Diagnostic test | – |
Primary outcome
Duration of vestibular-ocular reflex after the administration of nystagmus post-rotatory test in adolescent and adult population
Time frame: End of the nystagmus post rotatory test and end of the vestibular-ocular reflex
The post rotatory nystagmus test evaluates the duration of the vestibular-ocular reflex: how long its lats gives information about the perception of vestibular system. This reflex reflects the role of the vestibular system in ocular mechanisms (Mailloux et al., 2014). It is administered twice: clockwise and counterclockwise.After the administration the physiologic nystagmus appears, it is our vestibular-ocular reflex, and the examiner has to register the duration of it.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2021.
- Results publication: PubMed 25184463Mailloux Z, Leao M, Becerra TA, Mori AB, Soechting E, Roley SS, Buss N, Cermak SA. Modification of the postrotary nystagmus test for evaluating young children. Am J Occup Ther. 2014 Sep-Oct;68(5):514-21. doi: 10.5014/ajot.2014.011031.
- Individual participant dataSharing planned: No
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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.
Vico Rocío principal investigator
Quesada, Rocío Vico
Pedrero Yolanda principal investigator
Quesada, Rocío Vico
Zisa Nerina principal investigator
Quesada, Rocío Vico
Questions about this trial
What is this clinical trial studying?
An observational study of Vestibular Function Tests and Nystagmus Vestibular, run by Quesada, Rocío Vico.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 9 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vico Rocío (+34 658144741, rociovicoquesada@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of vestibular-ocular reflex after the administration of nystagmus post-rotatory test in adolescent and adult population (time frame: End of the nystagmus post rotatory test and end of the vestibular-ocular reflex). 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 NCT04788134, 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 9 Mar 2021.