Auditory NeuropathyNCT05666466
Noninvasive Diagnostic Techniques in Determination of Site of Lesion of Auditory Neuropathy Spectrum Disorder
An observational study of Auditory Neuropathy, run by Sohag University at 1 site in Egypt.
Trial summary
cross-sectional study of population who have ANSD Read more about this study
- Who is it for?
- Ages 12 to 50 years
- Conditions the study is for
- Auditory Neuropathy
- What is being tested?
- extratympanic electrocochleograhy
- How many people
- 25 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2022to 30 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
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
Who may be able to join
- Age between 12 and 50 years OAE and CM could be present disproportionate SRS to PTA level
Who cannot join
- proportionate ABR to PTA level Proportionate SRS to PTA level
- presnce ol lesions in CT or MRI
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Sohag Faculty of Medicine
Sohag, 82524
Mohammed Abdel Gaffar, MD, 00201099055507, dr_mghaffar@yahoo.com
About this study
Official title: Noninvasive Diagnostic Techniques in Determination of Site of Lesion of Auditory Neuropathy Spectrum Disorder(ANSD)
cross-sectional study of population who have ANSD
Read the 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
- Conditions
- Auditory Neuropathy
- Being tested
- extratympanic electrocochleograhy
- Keywords
- auditory neuropathy
- Medical subject headings
- Auditory neuropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
extratympanic electrocochleograhyDiagnostic test
Also called EchoG
electrophysiological test
| Study group | Role | What they receive |
|---|---|---|
| case group | age between 12 to 50 disproportionate SRS to PTA level presence of OAE presence of CM Normal MRI and CT Receives: Diagnostic Test: extratympanic electrocochleograhy | |
| control group | age and sex matched to study group Normal hearing sensitivity and excellent speech discrimination no CAPD Receives: Diagnostic Test: extratympanic electrocochleograhy |
What is being measured
The primary outcome is the main question the study is designed to answer.
determination of site of lesion of ANSD
differentiation between presynaptic and postsynaptic types of ANSD
Measured: one and half year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2022
- Study start1 Dec 2022
- Primary completion1 Jul 2023 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Auditory NeuropathyStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rania Fattouh Ahmad Khalil, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05666466
- Sponsor's protocol ID
- Soh-Med-22-12-16
- Status last verified
- Dec 2022
- First submitted
- 17 Dec 2022
- Last updated
- 30 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive Diagnostic Techniques in Determination of Site of Lesion of Auditory Neuropathy Spectrum Disorder(ANSD)
- ClinicalTrials.gov ID
- NCT05666466
- Acronym / sponsor ID
- Soh-Med-22-12-16
- Conditions
- Auditory Neuropathy
- Keywords
- auditory neuropathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 27 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
cross-sectional study of population who have ANSD
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| case group | – | Diagnostic Test: extratympanic electrocochleograhyage between 12 to 50 disproportionate SRS to PTA level presence of OAE presence of CM Normal MRI and CT |
| control group | – | Diagnostic Test: extratympanic electrocochleograhyage and sex matched to study group Normal hearing sensitivity and excellent speech discrimination no CAPD |
Who may qualify
- Ages
- 12 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (1 listed)
- Age between 12 and 50 years OAE and CM could be present disproportionate SRS to PTA level
Key exclusion criteria (2 listed)
- proportionate ABR to PTA level Proportionate SRS to PTA level
- presnce ol lesions in CT or MRI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| extratympanic electrocochleograhyAlso: EchoGelectrophysiological test | Diagnostic test | case group, control group |
Primary outcome
determination of site of lesion of ANSD
Time frame: one and half year
differentiation between presynaptic and postsynaptic types of ANSD
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Auditory Neuropathy, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rania Khalil, MSc (00201024493093, rania.khalil@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
determination of site of lesion of ANSD (time frame: one and half year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2022.