Auditory NeuropathyNCT06125015
Unexpected ABR Results in Patients Suspected With Auditory Neuropathy Spectrum Disorder
A study testing Hearing Thresholds Assessments in people with Auditory Neuropathy, run by Istanbul Medipol University Hospital.
Trial summary
This study aimed to assess the clinical evaluations and potential underlying pathologies in patients diagnosed with Auditory Neuropathy Spectrum Disorder (ANSD) who exhibited unusual results in audiological tests. Read more about this study
- Who is it for?
- Ages 0 to 46 years
- Conditions the study is for
- Auditory Neuropathy
- What is being tested?
- Hearing Thresholds Assessments
- How many people
- 11 participants
- Where
- No sites listed yet
- Study dates
- 20 Jan 2015to 30 Nov 2021
- Phase
- Interventional
- 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 0 to 46 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Presence of wave V with cochlear microphonics
Who cannot join
- Type B tympanogram
About this study
This study aimed to assess the clinical evaluations and potential underlying pathologies in patients diagnosed with Auditory Neuropathy Spectrum Disorder (ANSD) who exhibited unusual results in audiological tests. The research involved the retrospective analysis of audiological tests of 11 patients conducted by expert audiologists at Istanbul Medipol Mega Hospital between 2010 and 2020. These patients displayed abnormalities in their Auditory Brainstem Response (ABR) tests. The study sought to investigate patients with ANSD who presented atypical audiological findings, shedding light on the associated clinical aspects and potential causes of such anomalies.
- Conditions
- Auditory Neuropathy
- Being tested
- Hearing Thresholds Assessments
- Medical subject headings
- Auditory neuropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hearing Thresholds AssessmentsDiagnostic test
Auditory Neuropathy Spectrum Disorder (ANSD) is a type of hearing disorder that affects the transmission of sound signals from the inner ear to the brain. In individuals with ANSD, the outer hair cells in the cochlea, which are responsible for amplifying sound, typically function properly. However, there is a disruption in the transmission of auditory information from the cochlea to the auditory nerve and then to the brain. It is characterized by a mismatch between the results of objective hearing tests, such as Auditory Brainstem Response (ABR), and subjective hearing experiences. In ABR tests, the responses of the auditory nerve to sounds may be abnormal, while the individual perceives their hearing to be better than suggested by the test results. In this study we showed ANSD patients with abnormal ABR results by using ABR, Otoacoustic Emissions, Tympanometry and behavioral test batteries.
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring Hearing Thresholds with Electrophysiological Tests
Participants' hearing thresholds and cochlear microphonics evaluated by using Auditory Brainstem Responses and Otoacoustic Emissions.
Measured: 6 years
Evaluating Middle Ear Pathologies
Participants' middle ear pathologies evaluated by using Tympanometry
Measured: 6 years
Evaluating Hearing Thresholds by Using Behavioral Tests
Participants' reactions to sounds were assessed using Free Field Audiometry or headphones. These evaluations were conducted initially at the time of diagnosis and subsequently after the patients had started using hearing aids.
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study start20 Jan 2015
- Primary completion30 Nov 2021
- Study completion30 Nov 2021
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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Berna Özge MUTLU, Istanbul Medipol University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06125015
- Sponsor's protocol ID
- E-10840098-772.02-3627
- Status last verified
- Nov 2023
- First submitted
- 4 Nov 2023
- Last updated
- 9 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unexpected ABR Results in Patients Suspected With Auditory Neuropathy Spectrum Disorder
- ClinicalTrials.gov ID
- NCT06125015
- Acronym / sponsor ID
- E-10840098-772.02-3627
- Conditions
- Auditory Neuropathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 20 Jan 2015 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 9 Nov 2023 (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.
This study aimed to assess the clinical evaluations and potential underlying pathologies in patients diagnosed with Auditory Neuropathy Spectrum Disorder (ANSD) who exhibited unusual results in audiological tests. The research involved the retrospective analysis of audiological tests of 11 patients conducted by expert audiologists at Istanbul Medipol Mega Hospital between 2010 and 2020. These patients displayed abnormalities in their Auditory Brainstem Response (ABR) tests. The study sought to investigate patients with ANSD who presented atypical audiological findings, shedding light on the associated clinical aspects and potential causes of such anomalies.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 0 to 46 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Presence of wave V with cochlear microphonics
Key exclusion criteria (1 listed)
- Type B tympanogram
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 |
|---|---|---|
| Hearing Thresholds AssessmentsAuditory Neuropathy Spectrum Disorder (ANSD) is a type of hearing disorder that affects the transmission of sound signals from the inner ear to the brain. In individuals with ANSD, the outer hair cells in the cochlea, which are responsible for amplifying sound, typically function properly. However, there is a disruption in the transmission of auditory information from the cochlea to the auditory nerve and then to the brain. It is characterized by a mismatch between the results of objective hearing tests, such as Auditory Brainstem Response (ABR), and subjective hearing experiences. In ABR tests, the responses of the auditory nerve to sounds may be abnormal, while the individual perceives their hearing to be better than suggested by the test results. In this study we showed ANSD patients with abnormal ABR results by using ABR, Otoacoustic Emissions, Tympanometry and behavioral test batteries. | Diagnostic test | – |
Primary outcome
Measuring Hearing Thresholds with Electrophysiological Tests
Time frame: 6 years
Participants' hearing thresholds and cochlear microphonics evaluated by using Auditory Brainstem Responses and Otoacoustic Emissions.
Evaluating Middle Ear Pathologies
Time frame: 6 years
Participants' middle ear pathologies evaluated by using Tympanometry
Evaluating Hearing Thresholds by Using Behavioral Tests
Time frame: 6 years
Participants' reactions to sounds were assessed using Free Field Audiometry or headphones. These evaluations were conducted initially at the time of diagnosis and subsequently after the patients had started using hearing aids.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2023.
- Individual participant dataSharing planned: No
Related trials for Auditory Neuropathy
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First In Human Randomised Trial of Rincell-1 in Adults With a Cochlear Implant
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RecruitingPhase 3
Gene Therapy Trial for Otoferlin Gene-mediated Hearing Loss
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Not yet recruitingObservational study
Genetic Study of OTOF- Related Auditory Neuropathy Spectrum Disorder
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A Study of DB-OTO, an Adeno-Associated Virus (AAV) Based Gene Therapy, in Children/Infants, Adolescents and Adults With Hearing Loss Due to Otoferlin Mutations
Congenital Hearing Loss Secondary to Biallelic Mutations of the Otoferlin Gene (OTOF)
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Hearing Thresholds Assessments in people with Auditory Neuropathy, run by Istanbul Medipol University Hospital.
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 1 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: finished, as of the sponsor's last update on 9 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measuring Hearing Thresholds with Electrophysiological Tests (time frame: 6 years). The study lists 3 primary outcomes in all. 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 9 Nov 2023.