Skip to main content
OpenTrials
Completed

NCT Number: NCT06711653

Development of Bone-vestibular Evoked Myogenic Potential

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taipei City Hospital

Taipei, 106, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 20y-40y adult

Exclusion criteria

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

Treatment and study plan

Vestibular evoke myogenic potential

Diagnostic Test

routine Vestibular test

Primary outcomes

  1. Vemp response rate

    Time frame: up to 24 weeks

    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.

Sponsors and collaborators

Lead sponsor

Taipei City Hospital

Other Gov

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 2, 2024
Registry last updated
Dec 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.