Noninvasive Diagnostic Techniques in Determination of Sit... | NCT05666466

Studies
Noninvasive Diagnostic Techniques in Determination of Site of Lesion of Auditory Neuropathy Spectrum Disorder

NCT05666466

Sponsor

Sohag University

Status

Unknown status

Last Update Posted

Dec 30, 2022Actual

Enrollment

25Estimated

Phase

Not provided

Conditions

Auditory Neuropathy

Interventions

extratympanic electrocochleograhy

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2022Actual

Primary Completion Date

Jul 1, 2023Estimated

Completion Date

Dec 30, 2024Estimated

First Submitted Date

Dec 17, 2022

First Submission Date that Met QC Criteria

Dec 17, 2022

First Posted Date

Dec 27, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 29, 2022

Last Update Posted Date

Dec 30, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

cross-sectional study of population who have ANSD

Detailed Description

Cross-sectional nonivasive study including study and control group aiming to determine site of lesion of auditory neuropathy spectrum disorder either presynaptic or postsynaptic by using electrophysiological measures

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

25Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
extratympanic electrocochleograhy	Diagnostic Test	electrophysiological test	case group control group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
determination of site of lesion of ANSD	differentiation between presynaptic and postsynaptic types of ANSD	one and half year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

proportionate ABR to PTA level Proportionate SRS to PTA level

presnce ol lesions in CT or MRI

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

50 Years

Standard Ages

ChildAdult

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Rania Khalil, MSc	Contact	00201024493093		rania.khalil@med.sohag.edu.eg

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sohag Faculty of Medicine	Recruiting	Sohag		82524	Egypt

Type	Date	Date Unknown
Release	Feb 26, 2025
Reset	Mar 18, 2025

Submission Tracking

Estimated Results First Submitted Date

Feb 26, 2025

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Feb 26, 2025			Mar 18, 2025

Condition Browse Module

MeSH Terms

ID	Term
C538268	Auditory neuropathy

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided