- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05666466
Noninvasive Diagnostic Techniques in Determination of Site of Lesion of Auditory Neuropathy Spectrum Disorder
December 29, 2022 updated by: Rania Fattouh Ahmad Khalil, Sohag University
Noninvasive Diagnostic Techniques in Determination of Site of Lesion of Auditory Neuropathy Spectrum Disorder(ANSD)
cross-sectional study of population who have ANSD
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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
Study Type
Observational
Enrollment (Anticipated)
25
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: Rania Khalil, MSc
- Phone Number: 00201024493093
- Email: rania.khalil@med.sohag.edu.eg
Study Locations
-
-
-
Sohag, Egypt, 82524
- Recruiting
- Sohag faculty of medicine
-
Contact:
- Mohammed Abdel Gaffar, MD
- Phone Number: 00201099055507
- Email: dr_mghaffar@yahoo.com
-
-
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
12 years to 50 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
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
Description
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
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-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
case group
age between 12 to 50 disproportionate SRS to PTA level presence of OAE presence of CM Normal MRI and CT
|
electrophysiological test
Other Names:
|
|
control group
age and sex matched to study group Normal hearing sensitivity and excellent speech discrimination no CAPD
|
electrophysiological test
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
determination of site of lesion of ANSD
Time Frame: one and half year
|
differentiation between presynaptic and postsynaptic types of ANSD
|
one and half year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Actual)
December 1, 2022
Primary Completion (Anticipated)
July 1, 2023
Study Completion (Anticipated)
December 30, 2024
Study Registration Dates
First Submitted
December 17, 2022
First Submitted That Met QC Criteria
December 17, 2022
First Posted (Actual)
December 27, 2022
Study Record Updates
Last Update Posted (Actual)
December 30, 2022
Last Update Submitted That Met QC Criteria
December 29, 2022
Last Verified
December 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Neuromuscular Diseases
- Otorhinolaryngologic Diseases
- Ear Diseases
- Sensation Disorders
- Hearing Disorders
- Hearing Loss, Sensorineural
- Retrocochlear Diseases
- Hearing Loss
- Auditory Diseases, Central
- Peripheral Nervous System Diseases
- Hearing Loss, Central
Other Study ID Numbers
- Soh-Med-22-12-16
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 Auditory Neuropathy
-
Sohag UniversityRecruitingAuditory Neuropathy Spectrum Disorder,, Peripheral NeuropathyEgypt
-
Assistance Publique - Hôpitaux de ParisURC-CIC Paris Descartes Necker CochinCompletedCongenital Profound Hearing LossFrance
-
Rinri TherapeuticsKing's College LondonNot yet recruitingSensorineural Hearing Loss | Presbyacusis | Auditory NeuropathyUnited Kingdom
-
VA Loma Linda Health Care SystemNational Institute on Deafness and Other Communication Disorders (NIDCD)TerminatedAuditory Training and Auditory Efferent SystemUnited States
-
University of California, IrvineNational Institute on Aging (NIA)RecruitingAging | Auditory Perceptual ImpairmentUnited States
-
University Hospital, MontpellierNational Research Agency, FranceNot yet recruitingNoise Exposure | Auditory Fatigue | D001305 | Environmental Noise | Auditory PerformanceFrance
-
Istanbul Medipol University HospitalCompleted
-
University of Sao PauloCoordenação de Aperfeiçoamento de Pessoal de Nível Superior.Completed
-
University of Massachusetts, AmherstCompleted
-
National Institute of Neurological Disorders and...Completed