- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05543135
Aetiology of Asymmetrical Hearing Loss: A Retro-spective Study Thesis Submitted for Partial Fulfillment of Master Degree in Audio-Vestibular Medicine
September 14, 2022 updated by: Inas Mahmoud Mahrous, Sohag University
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
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Enas M Mahrous, resident doctor
- Phone Number: 01096769904
- Email: inas_mahmoud_post@med.sohag.edu.eg
Study Contact Backup
- Name: Mohamed A Abdelrahman, professor
Study Locations
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Sohag, Egypt
- Sohag university hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
all patients with asymmetrical hearing loss with age ranging 6 years old and more.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
cases
patients with asymmetrical hearing loss
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pure tone audiometry&immitancemetry
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Asymmetrical hearing loss
Time Frame: 1 year
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asymmetrical hearing loss using basic audiological evalution &imaging
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1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- Margolis RH, Saly GL. Asymmetric hearing loss: definition, validation, and prevalence. Otol Neurotol. 2008 Jun;29(4):422-31. doi: 10.1097/MAO.0b013e31816c7c09.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
September 20, 2022
Primary Completion (Anticipated)
September 1, 2023
Study Completion (Anticipated)
September 1, 2023
Study Registration Dates
First Submitted
September 14, 2022
First Submitted That Met QC Criteria
September 14, 2022
First Posted (Actual)
September 16, 2022
Study Record Updates
Last Update Posted (Actual)
September 16, 2022
Last Update Submitted That Met QC Criteria
September 14, 2022
Last Verified
September 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Soh-Med-22-07-09
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Asymmetrical Hearing Loss
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Advanced BionicsCompletedOtorhinolaryngologic Diseases | Ear Diseases | Hearing Loss | Hearing Disorders | Asymmetrical Hearing Loss | Single-Sided DeafnessUnited States
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Oticon MedicalCompletedEar Diseases | Hearing Loss, Conductive | Hearing Loss Mixed | Hearing Disability | Conductive Hearing Loss | Conductive Hearing Loss, Bilateral | Conductive Hearing Loss, UnilateralUnited Kingdom
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MED-EL Elektromedizinische Geräte GesmbHCompletedHearing Loss | Hearing Loss, Sensorineural | Hearing Loss, Bilateral | Hearing Loss, Conductive | Hearing Loss, Unilateral | Hearing Loss, MixedAustria, Germany, United Kingdom
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Oticon MedicalNot yet recruitingSensorineural Hearing Loss, Bilateral | Sensorineural Hearing Loss, Severe | Sensorineural Hearing Loss, Profound
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University of California, San FranciscoPatient-Centered Outcomes Research InstituteRecruitingHearing Loss | Hearing Loss, Sensorineural | Hearing Loss, Bilateral | Hearing Loss, Conductive | Hearing Loss, Noise-Induced | Hearing Loss, Unilateral | Hearing Loss, Mixed | Hearing Disorders in ChildrenUnited States
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Manchester University NHS Foundation TrustUniversity of ManchesterCompletedCochlear Hearing Loss | Sensorineural Hearing Loss, BilateralUnited Kingdom
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Truway Health, Inc.Enrolling by invitationSensorineural Hearing Loss | Tinnitus | Sudden Hearing Loss | Acoustic Trauma | Inner Ear Injury | Noise-Induced Hearing Loss | Vestibular DysfunctionUnited States
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Wonju Severance Christian HospitalRecruitingHearing Loss, Sudden | Sudden Hearing Loss | Hearing Loss, Idiopathic Sudden Sensorineural | SSNHL(Sudden Sensory Neural Hearing Loss)Korea, Republic of
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Envoy Medical CorporationActive, not recruitingSensorineural Hearing Loss | Sensorineural Hearing Loss (Disorder) | Sensorineural Hearing Loss, Bilateral | Sensorineural Hearing Loss, Severe | Sensorineural Hearing Loss, Profound | Sensori-Neural DeafnessUnited States
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Oticon MedicalCompletedConductive Hearing Loss | Conductive and Sensori-neural Hearing Loss in the Same Ear | Unilateral, Profound Sensori-neural Hearing LossUnited States
Clinical Trials on basic audiological evaluation
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Assiut UniversityNot yet recruitingCochlear Implant
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US Department of Veterans AffairsCompleted
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Institut PasteurRecruitingDeafness NeurosensoryFrance
-
MedtronicNeuroCompletedOveractive Bladder | Urgency-frequency Syndrome | Urinary Urge IncontinenceUnited States, Netherlands, Canada, United Kingdom
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Assiut UniversityNot yet recruiting
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University of Colorado, DenverNational Institutes of Health (NIH); National Institute on Deafness and Other...RecruitingHealthy Individuals | Hearing Loss, CentralUnited States
-
VA Office of Research and DevelopmentWalter Reed Army Medical CenterCompletedTraumatic Brain Injury | Hearing Loss | Central Auditory Processing DisorderUnited States
-
The Bionics Institute of AustraliaRecruitingHearing ImpairmentAustralia
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University Hospital, GhentWithdrawnConductive Hearing Loss | Unilateral Deafness | Mixed Hearing LossBelgium
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University of NottinghamNottingham University Hospitals NHS TrustCompletedHearing Loss | TinnitusUnited Kingdom