Cochlear TraumaNCT05795530
Vestibular Function in Cochlear Implants
An observational study of Cochlear Trauma and Vestibular Disorder, run by Charles University, Czech Republic at 1 site in Czechia.
Trial summary
The objective of this study is to identify possible preoperative risk factors including genetic background and to suggest the optimal test battery of vestibular function in cochlear implant recipients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cochlear Trauma, Vestibular Disorder, Deafness, Bilateral
- What is being tested?
- cochlear implantation
- Type of treatment
- Surgery or procedure
- How many people
- 57 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Oct 2018to 30 Jun 2020
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: 57 adult CI recipients The indication for surgery was hearing impairment. Round window approach was used preferably for insertion of the electrode array. Anamestic data as a history of hearing impairment, family history and the use of hearing aids were collected from all the patients. They underwent routine vestibular testing before and after the intervention.
Who may be able to join
- profound bilateral sensorineural hearing loss meeting criteria for cochlear implantation
Who cannot join
- profound unilateral sensorineural hearing loss meeting criteria for cochlear implantation
Trial locations and contacts
1 site in 1 country.
Czechia1 site
Department of Otorhinolaryngology and Head and Neck Surgery, 1st Faculty of Medicine Charles University and Motol University Hospital, Postgraduate Medical School
Prague, 15006
About this study
Official title: Genetic Background of Hearing Loss and Vestibular Function Evaluation Following Cochlear Implantation
The objective of this study is to identify possible preoperative risk factors including genetic background and to suggest the optimal test battery of vestibular function in cochlear implant recipients
Read the detailed description
The objective of this study is to identify possible preoperative risk factors including genetic background and to suggest the optimal test battery of vestibular function in cochlear implant recipients Participants underwent standard vestibular testing including video head impulse test (vHIT), vestibular evoked myogenic potentials (VEMP), subjective visual vertical and stabilometry before and after the surgery.
- Conditions
- Cochlear Trauma, Vestibular Disorder, Deafness, Bilateral
- Being tested
- cochlear implantation
- Keywords
- cochlear implant
- Medical subject headings
- Vestibular Diseases, Hearing Loss, Bilateral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cochlear implantationProcedure or surgery
surgery for bilateral hearing loss
| Study group | Role | What they receive |
|---|---|---|
| Cochlear implant recipients | 57 consecutive cochlear implant recipients Receives: Procedure: cochlear implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
vestibular function
semicircular canal function measured by vHIT
Measured: from 2 days before the intervention to 3 weeks after the intervention
vestibular function
otolith function measured by VEMP
Measured: from 2 days before the intervention to 3 weeks after the intervention
postural function
postural function and stability measured by stabilometry
Measured: from 2 days before the intervention to 3 weeks after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2023
- Study start1 Oct 2018
- Primary completion1 Mar 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cochlear TraumaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marketa Bonaventurova, Charles University, Czech Republic
- Investigators
- Zuzana Balatkova, Study chair, Dept Of ENT, 1st Faculty Of Medicine, University Hospital Motol
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05795530
- Sponsor's protocol ID
- CharlesUCZ
- Status last verified
- Feb 2024
- First submitted
- 21 Mar 2023
- Last updated
- 9 Feb 2024
- Results posted
- 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 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Background of Hearing Loss and Vestibular Function Evaluation Following Cochlear Implantation
- ClinicalTrials.gov ID
- NCT05795530
- Acronym / sponsor ID
- CharlesUCZ
- Conditions
- Cochlear Trauma, Vestibular Disorder, Deafness, Bilateral
- Keywords
- cochlear implant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 3 Apr 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.
The objective of this study is to identify possible preoperative risk factors including genetic background and to suggest the optimal test battery of vestibular function in cochlear implant recipients
Detailed description
The objective of this study is to identify possible preoperative risk factors including genetic background and to suggest the optimal test battery of vestibular function in cochlear implant recipients Participants underwent standard vestibular testing including video head impulse test (vHIT), vestibular evoked myogenic potentials (VEMP), subjective visual vertical and stabilometry before and after the surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cochlear implant recipients | – | Procedure: cochlear implantation57 consecutive cochlear implant recipients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 57 adult CI recipients The indication for surgery was hearing impairment. Round window approach was used preferably for insertion of the electrode array. Anamestic data as a history of hearing impairment, family history and the use of hearing aids were collected from all the patients. They underwent routine vestibular testing before and after the intervention.
Key inclusion criteria (1 listed)
- profound bilateral sensorineural hearing loss meeting criteria for cochlear implantation
Key exclusion criteria (1 listed)
- profound unilateral sensorineural hearing loss meeting criteria for cochlear implantation
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 implantationsurgery for bilateral hearing loss | Procedure or surgery | Cochlear implant recipients |
Primary outcome
vestibular function
Time frame: from 2 days before the intervention to 3 weeks after the intervention
semicircular canal function measured by vHIT
vestibular function
Time frame: from 2 days before the intervention to 3 weeks after the intervention
otolith function measured by VEMP
postural function
Time frame: from 2 days before the intervention to 3 weeks after the intervention
postural function and stability measured by stabilometry
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 Feb 2024.
- Individual participant dataSharing planned: No
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Regenerative Medicine and Stem Cell-Based Interventions for Inner Ear Trauma, Tinnitus, and Sensorineural Hearing Loss
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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.
Zuzana Balatkova study chair
Dept Of ENT, 1st Faculty Of Medicine, University Hospital Motol
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 Cochlear Trauma and Vestibular Disorder, run by Charles University, Czech Republic at 1 site in Czechia.
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 Feb 2024. 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 Czechia. 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?
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?
vestibular function (time frame: from 2 days before the intervention to 3 weeks after the intervention). 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 Feb 2024.