NCT06711653

Brief Summary

This study aims to evaluate the effects of different masking conditions on cervical vestibular evoked myogenic potential (cVEMP) responses. Vertical-axis vibrations (VAVs) of 500-Hz short-tone bursts (STB500) and 750-Hz short-tone bursts (STB750) were used to elicit cVEMP responses. These stimuli were delivered through a Mini-Shaker placed at the vertex (Cz) under three masking conditions: no masking (NOM), speech noise masking (SNM), and random interstimulus-interval tone bursts (rISITB). The study focused on testing protocols that can potentially improve unilateral VEMP testing and explore its clinical applicability.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2022

Shorter than P25 for not_applicable

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

November 7, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

November 21, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 2, 2024

Completed
Last Updated

December 2, 2024

Status Verified

November 1, 2024

Enrollment Period

6 months

First QC Date

November 21, 2024

Last Update Submit

November 26, 2024

Conditions

NoiseVestibular Disorder

Keywords

bone conductionmaskingnoiserandomvestibular evoked myogenic potentials

Outcome Measures

Primary Outcomes (1)

  • Vemp response rate

    This study investigates VEMP response rates under different frequencies (500 Hz, 750 Hz) and masking conditions (no masking, speech noise, random tone bursts) to evaluate the effects of masking on VEMP responses.

    up to 24 weeks

Study Arms (1)

Different Test Conditions

EXPERIMENTAL

one test group with different test conditions

Diagnostic Test: Vestibular evoke myogenic potential

Interventions

Vestibular evoke myogenic potentialDIAGNOSTIC_TEST

routine Vestibular test

Different Test Conditions

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • y-40y adult

You may not qualify if:

  • Having history of hearing loss or dizziness
  • failed hearing screening test
  • Having history of head or neck surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei City Hospital

Taipei, 106, Taiwan

Location

MeSH Terms

Conditions

Vestibular Diseases

Condition Hierarchy (Ancestors)

Labyrinth DiseasesEar DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Guo-She Lee

    Taipei City Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2024

First Posted

December 2, 2024

Study Start

November 7, 2022

Primary Completion

May 1, 2023

Study Completion

May 1, 2023

Last Updated

December 2, 2024

Record last verified: 2024-11

Locations

TW(1)