Relationship Between LS Chirp ABR and Speech-in-Noise Skills in Hidden Hearing Loss

NCT07230236 | Recruiting DMC

• 1 other identifier: 2025/379
• Study Type: observational
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hidden Hearing Loss; Cochlear Synaptopathy

Keywords

hidden hearing loss; cochlear synaptopathy; Level-Specific (LS) Chirp ABR; Hearing In Noise Test (HINT)

Outcome Measures

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.

  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

  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

  Within one month after completion of participant recruitment.

Study Arms (3)

Control group

Inclusion Criteria 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, Having no emotional or neurological problems that could interfere with the tests. Exclusion Criteria 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.

First study group

Inclusion Criteria 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 a chronic tinnitus complaint (≥3 months), Scoring 21 or above on the MoCA test, Having no emotional or neurological problems that could interfere with the tests. Exclusion Criteria 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.

Second study group

Inclusion Criteria 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 chronic tinnitus complaint, The mean scores on the questions assessing the ability to understand speech in noise in the "Speech Perception" subscale of the SSQ (Speech, Spatial, and Hearing Quality Scale) are below the normative value, Scoring 21 or above on the MoCA test, Having no emotional or neurological problems that could interfere with the tests. Exclusion Criteria 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.

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Probability sample method will be used.

You may qualify if:

• 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,
• Having no emotional or neurological problems that could interfere with the tests.

You may not qualify if:

• 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,
• Having bilateral pure-tone audiometry averages (500-1000-2000-4000 Hz) within the normal range (≤25 dB HL),
• Having a chronic tinnitus complaint (≥3 months),
• Scoring 21 or above on the MoCA test,
• Having no emotional or neurological problems that could interfere with the tests.
• 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,
• Having bilateral pure-tone audiometry averages (500-1000-2000-4000 Hz) within the normal range (≤25 dB HL),
• Having no chronic tinnitus complaint,
• Having an average score below 4.3 on the "Speech Perception" subscale of the Speech, Spatial and Qualities of Hearing Scale (SSQ),

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead
• Medipol University: collaborator

Study Sites (1)

Istanbul University-Cerrahpaşa

Istanbul, Turkey (Türkiye)

RECRUITING

Related Publications (7)

• Kara E, Aydin K, Akbulut AA, Karakol SN, Durmaz S, Yener HM, Gozen ED, Kara H. Assessment of Hidden Hearing Loss in Normal Hearing Individuals with and Without Tinnitus. J Int Adv Otol. 2020 Apr;16(1):87-92. doi: 10.5152/iao.2020.7062.

  PMID: 32209515 RESULT

• Lobarinas E, Salvi R, Ding D. Selective Inner Hair Cell Dysfunction in Chinchillas Impairs Hearing-in-Noise in the Absence of Outer Hair Cell Loss. J Assoc Res Otolaryngol. 2016 Apr;17(2):89-101. doi: 10.1007/s10162-015-0550-8. Epub 2015 Dec 21.

  PMID: 26691159 RESULT

• Kujawa SG, Liberman MC. Adding insult to injury: cochlear nerve degeneration after "temporary" noise-induced hearing loss. J Neurosci. 2009 Nov 11;29(45):14077-85. doi: 10.1523/JNEUROSCI.2845-09.2009.

  PMID: 19906956 RESULT

• Chambers AR, Resnik J, Yuan Y, Whitton JP, Edge AS, Liberman MC, Polley DB. Central Gain Restores Auditory Processing following Near-Complete Cochlear Denervation. Neuron. 2016 Feb 17;89(4):867-79. doi: 10.1016/j.neuron.2015.12.041. Epub 2016 Jan 28.

  PMID: 26833137 RESULT

• Gratias P, Nasr J, Affortit C, Ceccato JC, Francois F, Casas F, Pujol R, Pucheu S, Puel JL, Wang J. Impulse Noise Induced Hidden Hearing Loss, Hair Cell Ciliary Changes and Oxidative Stress in Mice. Antioxidants (Basel). 2021 Nov 25;10(12):1880. doi: 10.3390/antiox10121880.

  PMID: 34942983 RESULT

• Lopez-Poveda EA. Why do I hear but not understand? Stochastic undersampling as a model of degraded neural encoding of speech. Front Neurosci. 2014 Oct 30;8:348. doi: 10.3389/fnins.2014.00348. eCollection 2014.

  PMID: 25400543 RESULT

• Liu J, Stohl J, Overath T. Hidden hearing loss: Fifteen years at a glance. Hear Res. 2024 Mar 1;443:108967. doi: 10.1016/j.heares.2024.108967. Epub 2024 Jan 30.

  PMID: 38335624 RESULT

MeSH Terms

Conditions

Hearing Loss, Hidden

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Eyyup Kara, Asst. Prof.

  Istanbul University - Cerrahpasa

  STUDY CHAIR

Central Study Contacts

Cem Yeral, MSc

CONTACT

+90 539 402 78 46; cem.yeral@ogr.iuc.edu.tr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 10 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Cem Yeral

Study Record Dates

• First Submitted: October 2, 2025
• First Posted: November 17, 2025
• Study Start: August 20, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: November 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)