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Prevalence of Peripheral Neuropathy Among Patients With Auditory Neuropathy

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ClinicalTrials.gov Identifier: NCT06041360
Recruitment Status : Recruiting
First Posted : September 18, 2023
Last Update Posted : September 18, 2023
Sponsor:
Information provided by (Responsible Party):
Hend Abdelnasser Sayed, Sohag University

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Auditory Neuropathy Spectrum Disorder,, Peripheral Neuropathy Diagnostic Test: Pure tone audiometry PTA ,Speech audiometry ,Otoacoustic emission,Auditory evoked potentials including (ABR).

Study Design
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Study Type : Observational
Estimated 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 : August 1, 2023
Estimated Primary Completion Date : April 1, 2024
Estimated Study Completion Date : August 1, 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
study group Study group(Group1)

Thirty participants of the group will meet the following criteria Inclusion criteria:

  1. Age ranges from 12 to 50 years old.
  2. Disproportionate speech recognition score (SRS) with the hearing threshold level.
  3. The auditory brainstem response (ABR) test with no waveform or, disturbed waves or, detectable wave V at high intense stimulus.
  4. 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:

  1. Consistent SRS and ABR response with hearing threshold level.
  2. Abnormal finding in brain imaging.
  3. 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 Name: 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:

  1. Age and sex matched with the study group.
  2. 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 Name: sural nerve conduction velocity (SNCV),sural nerve action potential (amplitude) (SNAP),vibration perception threshold (VPT),Michigan Neuropathy Screening


Outcome Measures
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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 [ Time Frame: 1 year ]
    This measurement aims to determine the degree of disability on theses patients


Eligibility Criteria
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Ages Eligible for Study:   12 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
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
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
Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06041360


Contacts
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Contact: Hend A sayed, resident 01066935404 hendhend1995@gmail.com
Contact: Mohamed A Abdelrahman, professor

Locations
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Egypt
Sohag university Hospital Recruiting
Sohag, Egypt
Contact: Magdy M Amin, professor       PORTAL@MED.SOHAG.EDU.EG   
Sponsors and Collaborators
Sohag University
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

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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: September 18, 2023    Key Record Dates
Last Update Posted: September 18, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hearing Loss, Central
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Hearing Loss, Sensorineural
Hearing Loss
Hearing Disorders
Ear Diseases
 Otorhinolaryngologic Diseases
Auditory Diseases, Central
Retrocochlear Diseases
Brain Diseases
Central Nervous System Diseases
Sensation Disorders
Neurologic Manifestations