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Status unknownNCT04788134Updated Mar 9, 2021

Post- Rotatory Nystagmus Test: Normative Data for Spanish Adolescents and Adults

An observational study in Vestibular Function Tests and Nystagmus Vestibular, sponsored by Quesada, Rocío Vico. Status unknown. Open to participants aged 13 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-03-09.

Sponsored by Quesada, Rocío Vico · Observational

The sponsor has not verified this record recently (last verified Mar 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-crossover
Time perspective
Cross-sectional
Enrollment
163
Ages
13 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Vestibular Function Tests
  • Nystagmus Vestibular

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Keywords

  • vestibular function tests
  • nystagmus, physiologic
  • adult
  • adolescent
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Who can participate

Ages eligible
13 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

People over 13 years, that lives in the north, middle and south of Spain, and meet the selection criteria.

Inclusion criteria

  • People over 13 years of age.
  • Spanish-speaking population.
  • Signature of the informed consent.

Exclusion criteria

Exclusion Criteria:

  • 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.
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Study design

Observational model
Case-crossover
Time perspective
Cross-sectional
Enrollment
163 participants (estimated)
Patient registry
No

Interventions

  • Diagnostic testPost-rotatory nystagmus 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.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: End of the nystagmus post rotatory test and end of the vestibular-ocular reflex

06

Study locations

No study locations are listed for this record.

07

References and documents

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 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT04788134
Lead sponsor
Quesada, Rocío Vico
Responsible party
Rocío Vico Quesada (Quesada, Rocío Vico, Quesada, Rocío Vico) — Principal investigator
First posted
Mar 9, 2021
Start date
Apr 1, 2021 (estimated)
Primary completion
Jun 1, 2021 (estimated)
Completion
Sep 1, 2021 (estimated)
Last update
Mar 9, 2021

Study contacts

Vico Rocío
Contact
rociovicoquesada@gmail.com
+34 658144741
Pedrero Yolanda
Contact
yolandapedmar@hotmail.com
+ 34 697355054
Vico Rocío
principal investigator · Quesada, Rocío Vico
Pedrero Yolanda
principal investigator · Quesada, Rocío Vico
Zisa Nerina
principal investigator · Quesada, Rocío Vico

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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