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临床试验/NCT07230236
NCT07230236招募中不适用

Investigation of the Relationship Between LS Chirp ABR and Comprehension In Noise Skills In Individuals With Suspected Hidden Hearing Loss

Istanbul University - Cerrahpasa1 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2025年8月20日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
63
试验地点
1
主要终点
Correlation between LS CE-Chirp Auditory Brainstem Response (ABR) parameters and Hearing In Noise Test (HINT) performance

研究概览

简要总结

It is known that the underlying problem in Hidden Hearing Loss (HHL) is cochlear synaptopathy (CS) and that low-spontaneous-rate auditory nerve fibers play an important role in this pathology. Therefore, it is suggested that low-spontaneous-rate auditory nerve fibers are damaged in HHL. Consequently, LS CE-Chirp-evoked ABR and HINT, which assesses CS by presenting stimuli of varying intensities and characteristics to provide information about auditory nerve fibers, will be used to evaluate participants both objectively and subjectively.

Aim of the study:

The main aim of this study is to investigate the relationship between the amplitude and latency values obtained with LS CE-Chirp-stimulated ABR and the critical Signal-to-Noise Ratio (SNR) obtained from the Hearing in Noise Test (HINT) in individuals suspected of having HHL.

Hypotheses

H0: In individuals suspected of having HHL, there is no relationship between the amplitude values of waves I, III, and V obtained with LS CE-Chirp ABR at 80, 90, and 100 dBnHL and the I/V amplitude ratio and the critical SNR obtained from HINT.

H1: In individuals suspected of having HHL, there is a relationship between the amplitude values of waves I, III, and V obtained with LS CE-Chirp ABR at 80, 90, and 100 dBnHL and the I/V amplitude ratio, and the critical SNR obtained from HINT.

Expected Results:

The study will reveal how LS CE-Chirp stimulation affects ABR results in individuals suspected of having HHL, and the relationship between these results and HINT results will be examined. In this way, HHL will be evaluated both objectively (LS CE-Chirp ABR) and subjectively (HINT). Based on the findings, scientific outputs such as publications or projects are targeted.

Importance:

HHL has recently attracted increasing attention as a condition that significantly affects daily life. In today's world, where noise and noisy environments are prevalent, disadvantages arise in many aspects, particularly in communication. Therefore, the findings obtained in this study may contribute to a better understanding of HHL.

详细描述

Hidden Hearing Loss (HHL) is defined as the presence of normal pure-tone audiometric thresholds accompanied by self-reported listening difficulties, most notably problems understanding speech in noisy environments. Recent neurophysiological and histopathological evidence suggests that this condition is associated with cochlear synaptopathy-selective loss or dysfunction of the synapses between inner hair cells and low-spontaneous-rate (low-SR) type I auditory nerve fibers. Low-SR fibers are crucial for encoding suprathreshold acoustic signals and preserving speech perception in noise. Damage to these fibers can occur from noise exposure, aging, or other metabolic factors even when outer hair cells remain intact, thereby leaving conventional audiometry within normal limits.

Auditory Brainstem Response (ABR) testing provides an objective measure of neural synchrony along the auditory pathway. The amplitude and latency of early ABR waves, particularly Waves I, III, and V, reflect the temporal integrity of auditory nerve and brainstem transmission. Among these, Wave I amplitude is considered a peripheral marker of auditory nerve fiber activity, while Wave V represents the summated output of higher brainstem nuclei. A reduction in Wave I amplitude with preserved Wave V amplitude, or a decreased I/V ratio, is interpreted as an electrophysiological signature of cochlear synaptopathy.

Traditional ABR using click stimuli synchronizes neural responses primarily from the basal cochlear region. The introduction of chirp stimuli aimed to improve neural synchrony by compensating for cochlear travel-time delays. The Level-Specific (LS) CE-Chirp stimulus designed by Claus Elberling and Don allows the amplitude of Wave V to remain robust across intensities while providing frequency-specific timing. Yet, at high levels (80-100 dB nHL), LS CE-Chirp responses may demonstrate altered growth functions and latency patterns, potentially revealing subtle differences in suprathreshold neural coding compared to conventional clicks.

The current study adopts an observational, cross-sectional, correlational design to investigate whether electrophysiological indices derived from LS CE-Chirp-stimulated ABR are associated with behavioral speech-in-noise performance in individuals suspected of HHL. Participants with normal pure-tone thresholds will undergo both ABR and the Hearing In Noise Test (HINT), enabling exploration of the relationship between amplitude and latency measures of ABR waves and the critical signal-to-noise ratio (SNR-50) obtained behaviorally.

The scientific rationale for the study stems from the premise that reduced neural output from low-SR auditory fibers manifests as smaller Wave I amplitudes at high stimulation levels, producing diminished I/V ratios and flattened amplitude-growth slopes. These physiological patterns are expected to parallel poorer speech-in-noise perception, reflected by elevated SNR-50 values on HINT. Demonstrating a significant correlation between ABR parameters and HINT outcomes would thus support the hypothesis that LS CE-Chirp ABR can serve as an objective marker of suprathreshold auditory coding deficits in HHL.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Correlation between LS CE-Chirp Auditory Brainstem Response (ABR) parameters and Hearing In Noise Test (HINT) performance

时间窗: Within one month after the completion of participant recruitment.

This primary outcome will assess the correlation between amplitude (µV) values of Waves I, III, and V, and the V/I amplitude ratio, obtained using LS CE-Chirp-stimulated Auditory Brainstem Response (ABR) at 80, 90, and 100 dB nHL, and the critical signal-to-noise ratio (SNR, dB) obtained from the Hearing In Noise Test (HINT), which evaluates speech understanding in noise. ABR recordings will be collected using the Neurosoft Neuro-MEP-4 device, and HINT will be administered in a free-field condition. The degree and direction of correlation between the electrophysiological (ABR) and behavioral (HINT) measures will be analyzed using Pearson or Spearman correlation coefficients, depending on the distribution of the data.

次要结局

  • Changes in Wave I amplitude growth and I/V amplitude ratio across stimulus levels in LS CE-Chirp- and Click-evoked ABR(Within one month after completion of participant recruitment.)

研究者

发起方
Istanbul University - Cerrahpasa
申办方类型
Other
责任方
Principal Investigator
主要研究者

Cem Yeral

Research Assistant Cem Yeral

Istanbul University - Cerrahpasa

研究点 (1)

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