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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05543135
Other study ID # Soh-Med-22-07-09
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date September 20, 2022
Est. completion date September 2023

Study information

Verified date September 2022
Source Sohag University
Contact Enas M Mahrous, resident doctor
Phone 01096769904
Email inas_mahmoud_post@med.sohag.edu.eg
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date September 2023
Est. primary completion date September 2023
Accepts healthy volunteers
Gender All
Age group 6 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
basic audiological evaluation
pure tone audiometry&immitancemetry

Locations

Country Name City State
Egypt Sohag University Hospital Sohag

Sponsors (1)

Lead Sponsor Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

References & 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. — View Citation

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

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. Review. — View Citation

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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Asymmetrical hearing loss asymmetrical hearing loss using basic audiological evalution &imaging 1 year
See also
  Status Clinical Trial Phase
Completed NCT02811549 - Benefits of the HiResolution Bionic Ear System in Adults With Asymmetric Hearing Loss N/A