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CompletedNCT06711653Updated Dec 2, 2024

Development of Bone-vestibular Evoked Myogenic Potential

An interventional study of Vestibular evoke myogenic potential in Noise and Vestibular Disorder, sponsored by Taipei City Hospital. Completed at 1 site in Taiwan. Open to participants aged 20 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-02.

Sponsored by Taipei City Hospital · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Registered 2 years after the study started (first participant enrolled Nov 2022, registered Nov 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
20 Years to 40 Years
Sex
All
01

Study 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.

Read the detailed description

Participants and Ethics:

The study recruited 20 healthy adults (10 males and 10 females, aged 20-37 years), all of whom had normal otoscopic findings and no history of hearing issues. Ethical approval was obtained, and all participants provided informed consent.

Bone Conduction Vibrations (BCV):

Bone-conducted vibrations were generated using a SmartEP system and delivered via a Mini-Shaker transducer. Stimuli included 500 Hz and 750 Hz short-tone bursts (STB500 and STB750), calibrated to appropriate levels, with specific rise, plateau, and fall times.

Masking Conditions:

Masking sounds included speech noise (250-1000 Hz, calibrated at 100 dB SPL) and random interstimulus-interval tone bursts (rISITB, 500 Hz, 100 dB SPL).

Testing Procedure:

Vertical-axis BCV was delivered to the vertex (Cz) while participants maintained steady neck muscle tension in specified head positions. Electrodes were placed using a standard montage for cVEMP recording. Each side was tested under three masking conditions (NOM, SNM, rISITB) with a 24-hour interval between tests. Responses were recorded bilaterally and repeated for reproducibility.

Study Focus:

The study investigates the effects of different masking conditions on response characteristics, including latencies, amplitudes, and asymmetry ratios. The aim is to refine VEMP testing protocols, explore its potential for unilateral testing, and evaluate its applicability for specific vestibular organ assessments.

02

Conditions studied

  • Noise
  • Vestibular Disorder

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Keywords

  • bone conduction
  • masking
  • noise
  • random
  • vestibular evoked myogenic potentials
03

In context

Vestibular Diseases

172 studies on the registry are indexed under Vestibular Diseases; 41 are open to participants now.

This study's enrollment of 20 is below the median of 44 across 130 interventional studies indexed under Vestibular Diseases.

Browse Vestibular Diseases studies →

Lead sponsor

Taipei City Hospital is the lead sponsor of 56 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 20y-40y adult

Exclusion criteria

Exclusion Criteria:

  • Having history of hearing loss or dizziness
  • failed hearing screening test
  • Having history of head or neck surgery
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Different Test Conditions

    one test group with different test conditions

    Diagnostic Test: Vestibular evoke myogenic potential

Interventions

  • Diagnostic testVestibular evoke myogenic potential

    routine Vestibular test

06

What researchers measure

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.

    Time frame: up to 24 weeks

07

Study locations

1 site
  • Taipei City Hospital
    Taipei, 106, Taiwan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 2, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06711653
Lead sponsor
Taipei City Hospital
Responsible party
Sponsor
First posted
Dec 2, 2024
Start date
Nov 7, 2022
Primary completion
May 1, 2023
Completion
May 1, 2023
Last update
Dec 2, 2024

Study contacts

Guo-She Lee
principal investigator · Taipei City Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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