Relationship Between LS Chirp ABR and Speech-in-Noise Skills in Hidden Hearing Loss
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age20-60
SponsorIstanbul University - Cerrahpasa
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Being between 20 and 60 years of age,
Having bilateral pure-tone audiometry averages (500-1000-2000-4000 Hz) within the normal range (≤25 dB HL),
Having no tinnitus or auditory complaints,
Scoring 21 or above on the MoCA test,
Disqualifiers
Presence of peripheral and/or central hearing loss,
Presence of somatosensory tinnitus,
Presence of emotional and/or neurological problems that could interfere with the tests.
Being between 20 and 60 years of age,
Trial population
Probability sample method will be used.
Trial design
Design model
Case-control
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
63 Participants
are grouped into 3 trial groupsGroup A: Control group
Group B: First study group
Group C: Second study group
Trial outcomes
Primary outcomes
1
Correlation between LS CE-Chirp Auditory Brainstem Response (ABR) parameters and Hearing In Noise Test (HINT) performance
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.
Time frame
Within one month after the completion of participant recruitment.Secondary outcomes
1
Changes in Wave I amplitude growth and I/V amplitude ratio across stimulus levels in LS CE-Chirp- and Click-evoked ABR
This exploratory outcome will examine how Wave I amplitude growth (slope, µV/dB) and I/V amplitude ratio vary across stimulus intensities (80, 90, and 100 dB nHL) in both LS CE-Chirp- and Click-evoked Auditory Brainstem Responses (ABR). These metrics are considered indirect electrophysiological indicators of cochlear synaptopathy or low-spontaneous-rate auditory nerve fiber dysfunction. Amplitude values will be measured in microvolts (µV), and stimulus level increments will be expressed in decibels normalized hearing level (dB nHL). Analyses will include within-group comparisons of amplitude growth slopes and correlation of these electrophysiological measures with HINT critical SNR (dB) to explore the relationship between suprathreshold neural encoding and speech-in-noise performance.
Time frame
Within one month after completion of participant recruitment.Other outcomes
1
Correlation between Click-evoked Auditory Brainstem Response (ABR) parameters and Hearing In Noise Test (HINT) performance
This secondary outcome will evaluate the correlation between amplitude (µV) values of Waves I, III, and V, and the V/I amplitude ratio, obtained using Click-evoked 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 assesses speech understanding in noise. ABR measurements will be recorded using the Neurosoft Neuro-MEP-4 device, and HINT will be conducted in a free-field setup. The degree and direction of correlation between electrophysiological (ABR) and behavioral (HINT) measures will be analyzed using Pearson or Spearman correlation coefficients, depending on data normality.
Time frame
Within one month after completion of participant recruitment.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Istanbul University - Cerrahpasa
Lead sponsor
Medipol University
Collaborator
Source ClinicalTrials.gov