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Unexpected ABR Results in Patients Suspected With Auditory Neuropathy Spectrum Disorder

Sponsor
Istanbul Medipol University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT06125015
Collaborator
(none)
11
Enrollment
82.3
Actual Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Hearing Thresholds Assessments
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
11 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Unexpected ABR Results in Patients Suspected With Auditory Neuropathy Spectrum Disorder
Actual Study Start Date :
Jan 20, 2015
Actual Primary Completion Date :
Nov 30, 2021
Actual Study Completion Date :
Nov 30, 2021

Outcome Measures

Primary Outcome Measures

  1. Measuring Hearing Thresholds with Electrophysiological Tests [6 years]

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

  2. Evaluating Middle Ear Pathologies [6 years]

    Participants' middle ear pathologies evaluated by using Tympanometry

  3. Evaluating Hearing Thresholds by Using Behavioral Tests [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
0 Years to 46 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Presence of wave V with cochlear microphonics
Exclusion Criteria:
  • Type B tympanogram

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Istanbul Medipol University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Berna Özge MUTLU, Audiologist, Istanbul Medipol University Hospital
ClinicalTrials.gov Identifier:
NCT06125015
Other Study ID Numbers:
  • E-10840098-772.02-3627
First Posted:
Nov 9, 2023
Last Update Posted:
Nov 9, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Hearing Loss, Central

Study Results

No Results Posted as of Nov 9, 2023