NCT05666466

Brief Summary

cross-sectional study of population who have ANSD

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2022

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

December 17, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 27, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

December 30, 2022

Status Verified

December 1, 2022

Enrollment Period

7 months

First QC Date

December 17, 2022

Last Update Submit

December 29, 2022

Conditions

Auditory Neuropathy

Keywords

auditory neuropathy

Outcome Measures

Primary Outcomes (1)

  • determination of site of lesion of ANSD

    differentiation between presynaptic and postsynaptic types of ANSD

    one and half year

Study Arms (2)

case group

age between 12 to 50 disproportionate SRS to PTA level presence of OAE presence of CM Normal MRI and CT

Diagnostic Test: extratympanic electrocochleograhy

control group

age and sex matched to study group Normal hearing sensitivity and excellent speech discrimination no CAPD

Diagnostic Test: extratympanic electrocochleograhy

Interventions

extratympanic electrocochleograhyDIAGNOSTIC_TEST

electrophysiological test

Also known as: EchoG
case groupcontrol group

Eligibility Criteria

Age12 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

25 participants aged between 12 to 50 years old with disproportionate SRS to PTA level, ABR may be absent or with disturbed waves or wave 5 could be detected at high intense stimulus, OAE and CM could be present. CT and MRI are free

You may qualify if:

  • Age between 12 and 50 years OAE and CM could be present disproportionate SRS to PTA level

You may not qualify if:

  • proportionate ABR to PTA level Proportionate SRS to PTA level
  • presnce ol lesions in CT or MRI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag Faculty of Medicine

Sohag, 82524, Egypt

RECRUITING

MeSH Terms

Conditions

Auditory neuropathy

Central Study Contacts

Rania Khalil, MSc

CONTACT

00201024493093rania.khalil@med.sohag.edu.eg

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

December 17, 2022

First Posted

December 27, 2022

Study Start

December 1, 2022

Primary Completion

July 1, 2023

Study Completion

December 30, 2024

Last Updated

December 30, 2022

Record last verified: 2022-12

Locations

EG(1)