NCT05543135

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

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
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2022

Shorter than P25 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

First Submitted

Initial submission to the registry

September 14, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 16, 2022

Completed
4 days until next milestone

Study Start

First participant enrolled

September 20, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

September 16, 2022

Status Verified

September 1, 2022

Enrollment Period

12 months

First QC Date

September 14, 2022

Last Update Submit

September 14, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Asymmetrical hearing loss

    asymmetrical hearing loss using basic audiological evalution \&imaging

    1 year

Study Arms (1)

cases

patients with asymmetrical hearing loss

Diagnostic Test: basic audiological evaluation

Interventions

pure tone audiometry\&immitancemetry

Also known as: CT&MRI
cases

Eligibility Criteria

Age6 Years+
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag University Hospital

Sohag, Egypt

Location

Related Publications (4)

  • 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.

    PMID: 18453885BACKGROUND
  • Margolis RH, Saly GL. Asymmetric hearing loss: definition, validation, and prevalence. Otol Neurotol. 2008 Jun;29(4):422-31. doi: 10.1097/MAO.0b013e31816c7c09.

    PMID: 18418281BACKGROUND
  • Peng AW, Salles FT, Pan B, Ricci AJ. Integrating the biophysical and molecular mechanisms of auditory hair cell mechanotransduction. Nat Commun. 2011 Nov 1;2:523. doi: 10.1038/ncomms1533.

    PMID: 22045002BACKGROUND
  • Plack CJ, Barker D, Hall DA. Pitch coding and pitch processing in the human brain. Hear Res. 2014 Jan;307:53-64. doi: 10.1016/j.heares.2013.07.020. Epub 2013 Aug 11.

    PMID: 23938209BACKGROUND

Central Study Contacts

Enas M Mahrous, resident doctor

CONTACT

Mohamed A Abdelrahman, professor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident doctor at audiovestibular unit Qena general hospital

Study Record Dates

First Submitted

September 14, 2022

First Posted

September 16, 2022

Study Start

September 20, 2022

Primary Completion

September 1, 2023

Study Completion

September 1, 2023

Last Updated

September 16, 2022

Record last verified: 2022-09

Locations