Hearing Loss, SensorineuralNCT04070937
Correlation of Radiological Lesions With Vestibular Function in Patients With Bilateral Vestibulopathy
An observational study of Hearing Loss, Sensorineural and Bilateral Vestibular Deficiency, run by Jessa Hospital at 1 site in Belgium.
Trial summary
In 2014 radiologic lesions were detected at one or more semicircular canals using CT and MR imaging of temporal bone in subjects carrying the p.P51S mutation in COCH. These lesions are believed to present at more advanced stages of the hearing and vestibular deterioration. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Hearing Loss, Sensorineural, Bilateral Vestibular Deficiency, DFNA9
- What is being tested?
- vestibular test 1, vestibular test 2 and vestibular evoked myogenic potentials
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Sep 2019to 30 Oct 2026
- How long will I take part?
- 2 Years
- 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 to 90 years
- All sexes
- Adult, Older adult
Study population: all patients presenting at our Department of ENT with vestibular or balance disorders, in whom videonystagmography, video head impulse test and VEMP tests meet the Barany criteria for bilateral vestibulopathy.
Who may be able to join
- must meet the Barany criteria for bilateral vestibulopathy: bilaterally pathological horizontal angu- lar VOR gain <0.6, measured by the video-HIT5 or scleral-coil technique and/or
- reduced caloric response6 (sum of bither- mal max. peak SPV on each side <6◦/sec7) and/or
- reduced horizontal angular VOR gain <0.1 upon sinusoidal stimulation on a rota- tory chair (0.1 Hz, Vmax = 50◦ /sec) and a phase lead >68 degrees (time constant <5 sec).
- must be 18 or older
Who cannot join
- < 18 y
- does not meet Barany criteria for BV
- contraindication for CT and MR imaging
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Jessa Hospital
Hasselt, Limburg, 3500
sebastien P Janssens, MD, 011 337420, drsjanssens@gmail.com
sebastien PF Janssens, MD
About this study
In 2014 radiologic lesions were detected at one or more semicircular canals using CT and MR imaging of temporal bone in subjects carrying the p.P51S mutation in COCH. These lesions are believed to present at more advanced stages of the hearing and vestibular deterioration. Since then, other authors have described similar lesions in advanced non-genetic hearing and vestibular impairment as well.
The purpose of this study is therefore to assess the radiologic investigation using CT and MR imaging of temporal bone to all subjects presenting with bilateral vestibulopathy, using the Barany criteria, compared to the p.P51S population.
- Being tested
- vestibular test 1, vestibular test 2, vestibular evoked myogenic potentials, audiometry, CT and MR imaging of temporal bone
- Medical subject headings
- Hearing Loss, Sensorineural, Bilateral Vestibulopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vestibular test 1Diagnostic test
videonystagmography
vestibular test 2Diagnostic test
video head impulse test
vestibular evoked myogenic potentialsDiagnostic test
vestibular evoked myogenic potentials to measure the function of otolith organs
audiometryDiagnostic test
tonal liminar audiometric thresholds
CT and MR imaging of temporal boneDiagnostic test
Ct and MR imaging of temporal bone
p.P51S mutationGenetic
analysis of presence of p.P51S mutation in COCH
| Study group | Role | What they receive |
|---|---|---|
| study group | all patients at least 18 years of age who present bilateral vestibulopathy on vestibular investigations according to the Barany criteria Receives: Diagnostic Test: vestibular test 1; Diagnostic Test: vestibular test 2; Diagnostic Test: vestibular evoked myogenic potentials; Diagnostic Test: audiometry; Diagnostic Test: CT and MR imaging of temporal bone; Genetic: p.P51S mutation | |
| control group | DFNA9 patients carrying the p.P51S mutation in COCH gene presenting bilateral vestibulopathy according to the Barany criteria Receives: Diagnostic Test: vestibular test 1; Diagnostic Test: vestibular test 2; Diagnostic Test: vestibular evoked myogenic potentials; Diagnostic Test: audiometry; Diagnostic Test: CT and MR imaging of temporal bone; Genetic: p.P51S mutation |
What is being measured
The primary outcome is the main question the study is designed to answer.
CT and MR findings
presence of focal sclerosis or signal loss on CT \& MR at one or more semicircular canals
Measured: at time of recruitment
genetic test
p.P51S mutation in COCH gene
Measured: at time of recruitment
Secondary outcomes (4)
vestibular test 1
video nystagmography using caloric tests ; caloric tests: °/s
Measured: at time of recruitment
vestibular test 2
video head impulse test; gain for each SCC in °/s
Measured: at time of recruitment
vestibular test 3
vestibular evoked myogenic potentials: threshold in decibel normal hearing loss (dB nHL)
Measured: at time of recruitment
audiometry
tonal liminar audiometry using calibrated audiometer, threshold in dB HL
Measured: at time of recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start1 Sep 2019
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing Loss, SensorineuralStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Jessa Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sebastien Janssens de Varebeke, Jessa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04070937
- Sponsor's protocol ID
- JessaH-4
- Status last verified
- Aug 2021
- First submitted
- 21 Aug 2019
- Last updated
- 25 Aug 2021
- 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 25 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Radiological Lesions With Vestibular Function in Patients With Bilateral Vestibulopathy
- ClinicalTrials.gov ID
- NCT04070937
- Acronym / sponsor ID
- JessaH-4
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Jessa HospitalUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 28 Aug 2019 (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.
In 2014 radiologic lesions were detected at one or more semicircular canals using CT and MR imaging of temporal bone in subjects carrying the p.P51S mutation in COCH. These lesions are believed to present at more advanced stages of the hearing and vestibular deterioration. Since then, other authors have described similar lesions in advanced non-genetic hearing and vestibular impairment as well.
The purpose of this study is therefore to assess the radiologic investigation using CT and MR imaging of temporal bone to all subjects presenting with bilateral vestibulopathy, using the Barany criteria, compared to the p.P51S population.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | – | Diagnostic Test: vestibular test 1, Diagnostic Test: vestibular test 2, Diagnostic Test: vestibular evoked myogenic potentials, Diagnostic Test: audiometry, Diagnostic Test: CT and MR imaging of temporal bone, Genetic: p.P51S mutationall patients at least 18 years of age who present bilateral vestibulopathy on vestibular investigations according to the Barany criteria |
| control group | – | Diagnostic Test: vestibular test 1, Diagnostic Test: vestibular test 2, Diagnostic Test: vestibular evoked myogenic potentials, Diagnostic Test: audiometry, Diagnostic Test: CT and MR imaging of temporal bone, Genetic: p.P51S mutationDFNA9 patients carrying the p.P51S mutation in COCH gene presenting bilateral vestibulopathy according to the Barany criteria |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- all patients presenting at our Department of ENT with vestibular or balance disorders, in whom videonystagmography, video head impulse test and VEMP tests meet the Barany criteria for bilateral vestibulopathy.
Key inclusion criteria (4 listed)
- must meet the Barany criteria for bilateral vestibulopathy: bilaterally pathological horizontal angu- lar VOR gain <0.6, measured by the video-HIT5 or scleral-coil technique and/or
- reduced caloric response6 (sum of bither- mal max. peak SPV on each side <6◦/sec7) and/or
- reduced horizontal angular VOR gain <0.1 upon sinusoidal stimulation on a rota- tory chair (0.1 Hz, Vmax = 50◦ /sec) and a phase lead >68 degrees (time constant <5 sec).
- must be 18 or older
Key exclusion criteria (3 listed)
- < 18 y
- does not meet Barany criteria for BV
- contraindication for CT and MR imaging
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 |
|---|---|---|
| vestibular test 1videonystagmography | Diagnostic test | control group, study group |
| vestibular test 2video head impulse test | Diagnostic test | control group, study group |
| vestibular evoked myogenic potentialsvestibular evoked myogenic potentials to measure the function of otolith organs | Diagnostic test | control group, study group |
| audiometrytonal liminar audiometric thresholds | Diagnostic test | control group, study group |
| CT and MR imaging of temporal boneCt and MR imaging of temporal bone | Diagnostic test | control group, study group |
| p.P51S mutationanalysis of presence of p.P51S mutation in COCH | Genetic | control group, study group |
Primary outcome
CT and MR findings
Time frame: at time of recruitment
presence of focal sclerosis or signal loss on CT \& MR at one or more semicircular canals
genetic test
Time frame: at time of recruitment
p.P51S mutation in COCH gene
4 secondary outcomes
vestibular test 1
Time frame: at time of recruitment
vestibular test 2
Time frame: at time of recruitment
vestibular test 3
Time frame: at time of recruitment
audiometry
Time frame: at time of recruitment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2021.
- Individual participant dataSharing planned: No
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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 Hearing Loss, Sensorineural and Bilateral Vestibular Deficiency, run by Jessa Hospital at 1 site in Belgium.
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 4 inclusion and 3 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 25 Aug 2021. 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 Belgium. 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 sebastien p JanssensdeVarebeke, MD (011337420, drsjanssens@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CT and MR findings (time frame: at time of recruitment). 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 25 Aug 2021.