Sensorineural Hearing LossNCT04934605
Genotype-phenotype Correlation of SLC26A4 in CI Patients With EVA
An observational study of Sensorineural Hearing Loss and Enlarged Vestibular Aqueduct, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
Trial summary
To explore the genotype-phenotype correlation of SLC26A4 mutations in cochlear-implanted patients with enlarged vestibular aqueduct. Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- Sensorineural Hearing Loss, Enlarged Vestibular Aqueduct
- What is being tested?
- Cochlear implantation
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2010to 1 Jul 2021
- 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 0 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Subjects with sensorineural hearing loss and enlarged vestibular aqueduct.
Who may be able to join
- Bilateral severe-to-profound sensorineural hearing loss who received cochlear implantation.
- Bilateral or unilateral enlarged vestibular aqueduct (EVA) with or without Mondini malformation (IP-II) on temporal bone computed tomography (CT) and/or magnetic resonance imaging (MRI).
Who cannot join
- Hearing loss that is associated with symptoms which meet the criteria of already known syndromes.
- With other type of inner ear malformation.
About this study
Official title: A Genotype-phenotype Correlation of SLC26A4 Mutations in Cochlear-implanted Patients With Enlarged Vestibular Aqueduct
To explore the genotype-phenotype correlation of SLC26A4 mutations in cochlear-implanted patients with enlarged vestibular aqueduct.
Read the detailed description
Enlarged vestibular aqueduct (EVA) is one of the most common forms of inner ear malformation that cause sensorineural hearing loss (SNHL). Some patients with EVA present delayed, fluctuating, and progressive hearing loss, while the others are with congenital or sudden hearing loss. Cochlear implants (CI) have been widely used in patients with severe-profound SNHL. However, it is difficult to define the optimal timing of CI operations for patients with EVA. Mutations in SLC26A4 are known to be responsible for EVA. This study is to explore the genotype-phenotype correlation of SLC26A4 mutations in cochlear-implanted patients with EVA.
- Being tested
- Cochlear implantation
- Keywords
- enlarged vestibular aqueduct, SLC26A4, cochlear implant
- Medical subject headings
- Hearing Loss, Sensorineural, Deafness, Autosomal Recessive 4
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cochlear implantationProcedure or surgery
Cochlear implantation
What is being measured
The primary outcome is the main question the study is designed to answer.
Cochlear implant age
Age of cochlear implantation.
Measured: Immediately after cochlear implantation
Duration of hearing loss
Time between found of hearing loss and cochlear implantation.
Measured: Immediately after cochlear implantation
Secondary outcomes (2)
Type of initial hearing loss
Prelingual or postlingual; Hearing aid can or cannot benefit
Measured: On the 1 day of recruitment.
Type of hearing loss progression
Initial profound, sudden, or fluctuating hearing loss.
Measured: Immediately after cochlear implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2021
- Study start1 May 2010
- Primary completion1 May 2021
- Study completion1 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sensorineural Hearing LossStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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 only
- Time perspective
- Retrospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiao Liu, MD, Principal investigator, Department of Otorhinolaryngology, 2nd Affiliated Hospital, School of Medicine, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04934605
- Sponsor's protocol ID
- 2013-007
- Status last verified
- Apr 2021
- First submitted
- 10 Jun 2021
- Last updated
- 22 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Genotype-phenotype Correlation of SLC26A4 Mutations in Cochlear-implanted Patients With Enlarged Vestibular Aqueduct
- ClinicalTrials.gov ID
- NCT04934605
- Acronym / sponsor ID
- 2013-007
- Keywords
- enlarged vestibular aqueduct, SLC26A4, cochlear implant
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 May 2010 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 1 Jul 2021 (estimated)
- First posted
- 22 Jun 2021 (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.
To explore the genotype-phenotype correlation of SLC26A4 mutations in cochlear-implanted patients with enlarged vestibular aqueduct.
Detailed description
Enlarged vestibular aqueduct (EVA) is one of the most common forms of inner ear malformation that cause sensorineural hearing loss (SNHL). Some patients with EVA present delayed, fluctuating, and progressive hearing loss, while the others are with congenital or sudden hearing loss. Cochlear implants (CI) have been widely used in patients with severe-profound SNHL. However, it is difficult to define the optimal timing of CI operations for patients with EVA. Mutations in SLC26A4 are known to be responsible for EVA. This study is to explore the genotype-phenotype correlation of SLC26A4 mutations in cochlear-implanted patients with EVA.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Subjects with sensorineural hearing loss and enlarged vestibular aqueduct.
Key inclusion criteria (2 listed)
- Bilateral severe-to-profound sensorineural hearing loss who received cochlear implantation.
- Bilateral or unilateral enlarged vestibular aqueduct (EVA) with or without Mondini malformation (IP-II) on temporal bone computed tomography (CT) and/or magnetic resonance imaging (MRI).
Key exclusion criteria (2 listed)
- Hearing loss that is associated with symptoms which meet the criteria of already known syndromes.
- With other type of inner ear malformation.
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 |
|---|---|---|
| Cochlear implantationCochlear implantation | Procedure or surgery | – |
Primary outcome
Cochlear implant age
Time frame: Immediately after cochlear implantation
Age of cochlear implantation.
Duration of hearing loss
Time frame: Immediately after cochlear implantation
Time between found of hearing loss and cochlear implantation.
2 secondary outcomes
Type of initial hearing loss
Time frame: On the 1 day of recruitment.
Type of hearing loss progression
Time frame: Immediately after cochlear implantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2021.
- Individual participant dataSharing planned: Undecided
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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.
Xiao Liu, MD principal investigator
Department of Otorhinolaryngology, 2nd Affiliated Hospital, School of Medicine, Zhejiang University
Questions about this trial
What is this clinical trial studying?
An observational study of Sensorineural Hearing Loss and Enlarged Vestibular Aqueduct, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
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 2 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 22 Jun 2021. 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?
Results are not available in the source record.
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?
Cochlear implant age (time frame: Immediately after cochlear implantation). The study lists 2 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 22 Jun 2021.