Aetiology of Asymmetrical Hearing Loss: A Retro-spective... | NCT05543135

Status Module

Record Verification Date

Sep 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 20, 2022Estimated

Primary Completion Date

Sep 2023Estimated

Completion Date

Sep 2023Estimated

First Submitted Date

Sep 14, 2022

First Submission Date that Met QC Criteria

Sep 14, 2022

First Posted Date

Sep 16, 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

Sep 14, 2022

Last Update Posted Date

Sep 16, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Inas Mahmoud Mahrous, resident doctor at audiovestibular unit Qena general hospital, Sohag UniversityPrincipal Investigator

Lead Sponsor

Sohag UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

Hearing loss maybe: -Symmetrical: in which the severity and pattern of hearing loss are the same in each ear. Or -Asymmetrical: is defined as binaural difference in bone conduction thresholds of >10 dB at two consecutive frequencies or >20 dB at one frequency (0.25-8.0 kHz), Poorer speech perception will often accompany poorer hearing and may be the reason for the patient's presentation .Unilateral or asymmetrical sensorineural hearing loss is important to discern, as it is an important risk factor for auditory nerve tumors (i.e. vestibular schwannoma) which is a life threatening condition, and in such cases further investigation is required (i.e. MRI scan) unless there is a known reason for the asymmetry, Several reports have recommended that further evaluation, especially expensive imaging studies, be conducted to rule out acoustic tumors when AHL is present

Detailed Description

Not provided

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

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
cases		patients with asymmetrical hearing loss	Diagnostic Test: basic audiological evaluation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
basic audiological evaluation	Diagnostic Test	pure tone audiometry&immitancemetry	cases

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Asymmetrical hearing loss	asymmetrical hearing loss using basic audiological evalution &imaging	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age: 6 years old and more.
Sex: male and female.

Exclusion Criteria:

Age: less than 6 years old.
Patients with symmetrical hearing loss.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

all patients with asymmetrical hearing loss with age ranging 6 years old and more.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Enas M Mahrous, resident doctor	Contact	01096769904		inas_mahmoud_post@med.sohag.edu.eg
Mohamed A Abdelrahman, professor	Contact

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sohag University Hospital		Sohag			Egypt

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18453885	Background	Dunn CC, Tyler RS, Oakley S, Gantz BJ, Noble W. Comparison of speech recognition and localization performance in bilateral and unilateral cochlear implant users matched on duration of deafness and age at implantation. Ear Hear. 2008 Jun;29(3):352-9. doi: 10.1097/AUD.0b013e318167b870.
18418281	Background

Type	Date	Date Unknown
Release	Jul 10, 2024
Reset	Oct 11, 2024