Prevalence of Peripheral Neuropathy Among Patients With Auditory Neuropathy

Sponsor
Sohag University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06041360
Collaborator
(none)
60
1
12
5

Study Details

Study Description

Brief Summary

Auditory neuropathy/ dys-synchrony/ peri-synaptic audiopathy (AN) are terms used to describe a specific hearing disorder with a disturbed auditory neural response in presence of normal cochlear function. Initially reported as early as the 1970s by ( Hinchcliffe et al) after observation of the patients with normal hearing thresholds, who had difficulty to detect the sounds especially in presence of background noise . Auditory Neuropathy is characterized by five integral features that distinguish it from other types of hearing loss. These are: Variable audiometric results anywhere from normal hearing to Sensorineural hearing loss of any degree up to profound hearing loss showing unusual audiometric pattern , Preserved outer hair cells (OHCs) responses such as otoacoustic emissions (OAEs) and/or cochlear microphonics (CM) , Altered neural processing such abnormal auditory brainstem responses (ABRs) with a reduced or absent wave V , Poor speech perception with poor speech recognition score that seems out of proportion compared to their pure-tone detection thresholds. , absent stapedial reflexes to the ipsilateral and contralateral tone at a 110-dB hearing level .

In 2008 it was found that AN does not represent a single disease entity but it is a heterogeneous disease category with a wide range of hearing loss types ,etiologies , age and clinical manifestations hence the adoption of the term auditory neuropathy spectrum disorder (ANSD) by an International Newborn Hearing Screening Conference held in Italy following a comprehensive study of newborn hearing test results.

The prevalence of ANSD is variable in published studies from (0.23 to 15%) among hearing impaired individuals . Regarding the underlying etiological factors, auditory neuropathy can be congenital or acquired . AN without the involvement of the neurological system has been termed as primary auditory neuropathy (PAN).

Peripheral neuropathy is not a constant finding in all patients with this hearing disorder , AN may occur in the afferent pathway of acoustic nerve, probably accompanied by the pathological changes of efferent nerve in the olivocochlear system inside the brainstem Our study is conducted to detect the prevalence of peripheral neuropathy among patients with auditory neuropathy spectrum disorder .

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Pure tone audiometry PTA ,Speech audiometry ,Otoacoustic emission,Auditory evoked potentials including (ABR).

Study Design

Study Type:
Observational
Anticipated Enrollment :
60 participants
Observational Model:
Case-Crossover
Time Perspective:
Prospective
Official Title:
Prevalence of Peripheral Neuropathy Among Patients With Auditory Neuropathy
Actual Study Start Date :
Aug 1, 2023
Anticipated Primary Completion Date :
Apr 1, 2024
Anticipated Study Completion Date :
Aug 1, 2024

Arms and Interventions

Arm Intervention/Treatment
study group Study group(Group1)

Thirty participants of the group will meet the following criteria Inclusion criteria: Age ranges from 12 to 50 years old. Disproportionate speech recognition score (SRS) with the hearing threshold level. The auditory brainstem response (ABR) test with no waveform or, disturbed waves or, detectable wave V at high intense stimulus. The otoacoustic emission (OAE) and/or cochlear microphonic (CM) potential may be present. Exclusion criteria: While the participants who have these criteria will be excluded from the study: Consistent SRS and ABR response with hearing threshold level. Abnormal finding in brain imaging. Patients with history of diabetes and/or other causes of peripheral neuropathy.

Diagnostic Test: Pure tone audiometry PTA ,Speech audiometry ,Otoacoustic emission,Auditory evoked potentials including (ABR).
Neurological tests for diagnosis of peripheral neuropathy
Other Names:
  • sural nerve conduction velocity (SNCV),sural nerve action potential (amplitude) (SNAP),vibration perception threshold (VPT),Michigan Neuropathy Screening
  • Control group (Group 2)

    Thirty participants have the following criteria: Age and sex matched with the study group. Patients with sensorineural hearing loss with degree of hearing matched with study group

    Diagnostic Test: Pure tone audiometry PTA ,Speech audiometry ,Otoacoustic emission,Auditory evoked potentials including (ABR).
    Neurological tests for diagnosis of peripheral neuropathy
    Other Names:
  • sural nerve conduction velocity (SNCV),sural nerve action potential (amplitude) (SNAP),vibration perception threshold (VPT),Michigan Neuropathy Screening
  • Outcome Measures

    Primary Outcome Measures

    1. Measuring the prevalence of peripheral neuropathy among patients with auditory neuropathy spectrum disorder using The Michigan neuropathy screening instrument Questionnaire and Examination [1 year]

      This measurement aims to determine the degree of disability on theses patients

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Age ranges from 12 to 50 years old.

    • Disproportionate speech recognition score (SRS) with the hearing threshold level.

    • The auditory brainstem response (ABR) test with no waveform or, disturbed waves or, detectable wave V at high intense stimulus.

    • The otoacoustic emission (OAE) and/or cochlear microphonic (CM) potential may be present.

    Exclusion Criteria:
    • While the participants who have these criteria will be excluded from the study:

    • Consistent SRS and ABR response with hearing threshold level.

    • Abnormal finding in brain imaging.

    • Patients with history of diabetes and/or other causes of peripheral neuropathy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sohag university Hospital Sohag Egypt

    Sponsors and Collaborators

    • Sohag University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Hend Abdelnasser Sayed, Resident-Audiovestibular medicine unit of ENT department-sohag hospital university, Sohag University
    ClinicalTrials.gov Identifier:
    NCT06041360
    Other Study ID Numbers:
    • Soh-Med-23-07-08MS
    First Posted:
    Sep 18, 2023
    Last Update Posted:
    Sep 18, 2023
    Last Verified:
    Sep 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 18, 2023