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Completed

NCT Number: NCT06125015

Unexpected ABR Results in Patients Suspected With Auditory Neuropathy Spectrum Disorder

This study aimed to assess the clinical evaluations and potential underlying pathologies in patients diagnosed with Auditory Neuropathy Spectrum Disorder (ANSD) who exhibited unusual results in audiological tests. The research involved the retrospective analysis of audiological tests of 11 patients conducted by expert audiologists at Istanbul Medipol Mega Hospital between 2010 and 2020. These patients displayed abnormalities in their Auditory Brainstem Response (ABR) tests. The study sought to investigate patients with ANSD who presented atypical audiological findings, shedding light on the associated clinical aspects and potential causes of such anomalies.

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Key information

Conditions

Age range

0 year–46 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Presence of wave V with cochlear microphonics

Exclusion criteria

  • Type B tympanogram

Treatment and study plan

Hearing Thresholds Assessments

Diagnostic Test

Auditory Neuropathy Spectrum Disorder (ANSD) is a type of hearing disorder that affects the transmission of sound signals from the inner ear to the brain. In individuals with ANSD, the outer hair cells in the cochlea, which are responsible for amplifying sound, typically function properly. However, there is a disruption in the transmission of auditory information from the cochlea to the auditory nerve and then to the brain. It is characterized by a mismatch between the results of objective hearing tests, such as Auditory Brainstem Response (ABR), and subjective hearing experiences. In ABR tests, the responses of the auditory nerve to sounds may be abnormal, while the individual perceives their hearing to be better than suggested by the test results. In this study we showed ANSD patients with abnormal ABR results by using ABR, Otoacoustic Emissions, Tympanometry and behavioral test batteries.

Primary outcomes

  1. Measuring Hearing Thresholds with Electrophysiological Tests

    Time frame: 6 years

    Participants' hearing thresholds and cochlear microphonics evaluated by using Auditory Brainstem Responses and Otoacoustic Emissions.

  2. Evaluating Middle Ear Pathologies

    Time frame: 6 years

    Participants' middle ear pathologies evaluated by using Tympanometry

  3. Evaluating Hearing Thresholds by Using Behavioral Tests

    Time frame: 6 years

    Participants' reactions to sounds were assessed using Free Field Audiometry or headphones. These evaluations were conducted initially at the time of diagnosis and subsequently after the patients had started using hearing aids.

Sponsors and collaborators

Lead sponsor

Istanbul Medipol University Hospital

Other

Registry information

Important dates

Study start
2015
Primary completion
2021
Study completion
2021
First posted
Nov 9, 2023
Registry last updated
Nov 9, 2023

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.

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