NCT05141734

Brief Summary

This study aimed to investigate whether there is a relationship between nystagmus intensity and vestibular-ocular reflex gains by comparing Videonystagmography and video head impulse test in patients with posterior semicircular canal-benign paroxysmal positional vertigo.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 15, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 11, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2020

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

November 19, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 2, 2021

Completed
Last Updated

December 2, 2021

Status Verified

November 1, 2021

Enrollment Period

9 months

First QC Date

November 19, 2021

Last Update Submit

November 19, 2021

Conditions

Positional VertigoReflexes, Vestibo-OcularNystagmus Vestibular

Keywords

vestibular function testsHead Impulse Testsemicircular canals

Outcome Measures

Primary Outcomes (1)

  • Comparison of nystagmus intensity and vestibulo-ocular reflex gains in patients with benign paroxysmal positional vertigo

    The vestibulo-ocular reflex (VOR) gains and the slow phase velocity (SPV) of nystagmus were compared in patients with benign paroxysmal positional vertigo.

    2019-2010 (15 months)

Study Arms (2)

BPPV (benign paroxysmal positional vertigo)

VOR gains were measured by vHIT in both the study group and the control group. The SPV values of the nystagmus observed during the Dix-Hallpike maneuver in the study group were recorded by Videonystagmography (VNG) and compared with the VOR gains.

Diagnostic Test: The relationship between the vestibulo-ocular reflex (VOR) gains and the slow phase velocity (SPV)

Control

VOR gains were measured by vHIT in both the study group and the control group. The SPV values of the nystagmus observed during the Dix-Hallpike maneuver in the study group were recorded by Videonystagmography (VNG) and compared with the VOR gains.

Diagnostic Test: The relationship between the vestibulo-ocular reflex (VOR) gains and the slow phase velocity (SPV)

Interventions

The relationship between the vestibulo-ocular reflex (VOR) gains and the slow phase velocity (SPV)DIAGNOSTIC_TEST

The vestibulo-ocular reflex (VOR) gains were measured by video Head Impulse Test (vHIT) in both the study group and the control group. The slow phase velocity (SPV) values of the nystagmus observed during the Dix-Hallpike maneuver in the study group were recorded by Videonystagmography (VNG) and compared with the VOR gains.

BPPV (benign paroxysmal positional vertigo)Control

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The patients included in the study group were diagnosed with isolated benign paroxysmal positional vertigo (BPPV) according to clinical symptoms.

You may qualify if:

  • Patients with isolated benign paroxysmal positional vertigo were included in the study group.
  • The patients included in the control group were composed of those who did not complain of vertigo.

You may not qualify if:

  • Participants with a history of neuro-otologic disease, an orthopedic disease that prevents neck movements, and any disease or surgery that causes impairment in ocular movements were excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Merih Onal

Konya, Turkey (Türkiye)

Location

Related Publications (1)

  • Onal M, Aygun A, Colpan B, Karakayaoglu H, Onal O. Correlation between nystagmus intensity and vestibular-ocular reflex gain in benign paroxysmal positional vertigo: A prospective, clinical study. J Vestib Res. 2023;33(2):115-125. doi: 10.3233/VES-220106.

    PMID: 36776086DERIVED

MeSH Terms

Conditions

Vertigo

Interventions

Reflex, Vestibulo-Ocular

Condition Hierarchy (Ancestors)

Vestibular DiseasesLabyrinth DiseasesEar DiseasesOtorhinolaryngologic DiseasesNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Vestibulocochlear Physiological PhenomenaPhysiological PhenomenaReflexNervous System Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Merih Onal, MD

    Selcuk University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Selcuk University Faculty of Medicine

Study Record Dates

First Submitted

November 19, 2021

First Posted

December 2, 2021

Study Start

April 15, 2019

Primary Completion

January 11, 2020

Study Completion

July 10, 2020

Last Updated

December 2, 2021

Record last verified: 2021-11

Locations

TU(1)