Hearing Loss, SensorineuralNCT04066270
Inventory of Radiological and Vestibular Function in Cochlear Implant Candidates
An observational study of Hearing Loss, Sensorineural and Bilateral Vestibular Deficiency, run by Jessa Hospital at 1 site in Belgium.
Trial summary
In 2014 radiological lesions at one or more semicircular canals (SCC) were described using CT \& MR imaging in subjects presenting advanced hearing and vestibular deterioration caused by the p.P51S mutation in COCH. 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?
- video nystagmography
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Sep 2019to 30 Dec 2023
- 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
- No healthy volunteers
- Adult, Older adult
Study population: -all patients with severe hearing loss who are eligible for cochlear implantation who do not carry the p.P51S mutation in COCH and are at least 18 years of age
Who may be able to join
- must be eligible for cochlear implantation
- must be 18 years of age or older
Who cannot join
- <18 years of age
- not eligible to undergo vestibular tests, especially videonystagmography
- contra-indication for MR or CT
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 radiological lesions at one or more semicircular canals (SCC) were described using CT \& MR imaging in subjects presenting advanced hearing and vestibular deterioration caused by the p.P51S mutation in COCH. Similar lesions were also described in other non-genetic advanced hearing and vestibular deterioration as well. With this prospective observational study it is the purpose to inventory imaging results of candidates for cochlear implantation which are routinely performed during the preoperative work up, since these patient present severe hearing impairment at both ears. A considerable part of them might present vestibular deterioration as well. It is the purpose to detect possible presence of these SCC lesions on CT and MR in this population and the prevalence of these lesions compared to DFNA9 patients.
- Being tested
- video nystagmography
- 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.
video nystagmographyDiagnostic test
Also called video head impulse test, c & o VEMP (vestibular-evoked myogenic potentials), CT scan temporal bone, MR temporal bone
routine test battery applied to all cochlear implant candidates
| Study group | Role | What they receive |
|---|---|---|
| study group | candidates for cochlear implantation 18 years or older, who are eligible for implantation for the indication of bilateral severe hearing loss or single sided deafness.
clinical audiometric and vestibular investigations, CT and MR imaging of petrous bone Receives: Diagnostic Test: video nystagmography | |
| control group | Symptomatic DFNA9 patients carrying the p.P51S mutation in COCH, presenting the radiologic semicircular canal lesion(s) on CT and/or MR.
clinical audiometric and vestibular investigations, CT and MR imaging of petrous bone Receives: Diagnostic Test: video nystagmography |
What is being measured
The primary outcome is the main question the study is designed to answer.
CT/MR of SCC
lesions to one or more semicircular canals on CT and/or MR of temporal bone
Measured: at time of recruitment
p.P51S
carriers hip of p.P51S mutation in COCH
Measured: at time of recruitment
Secondary outcomes (4)
audiometry
tonale liminar audiometry thresholds
Measured: at time of recruitment
vestibular function 1
video nystagmography
Measured: at time of recruitment
vestibular function 2
video head impulse test
Measured: at time of recruitment
vestibular function 3
vestibular evoked myogenic potentials
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 posted26 Aug 2019
- Study start1 Sep 2019
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Dec 2023 (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
- NCT04066270
- Sponsor's protocol ID
- JessaH-3
- Status last verified
- Mar 2022
- First submitted
- 21 Aug 2019
- Last updated
- 31 Mar 2022
- 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 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inventory of Radiological and Vestibular Function in Cochlear Implant Candidates
- ClinicalTrials.gov ID
- NCT04066270
- Acronym / sponsor ID
- JessaH-3
- 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 Dec 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 26 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 radiological lesions at one or more semicircular canals (SCC) were described using CT \& MR imaging in subjects presenting advanced hearing and vestibular deterioration caused by the p.P51S mutation in COCH. Similar lesions were also described in other non-genetic advanced hearing and vestibular deterioration as well. With this prospective observational study it is the purpose to inventory imaging results of candidates for cochlear implantation which are routinely performed during the preoperative work up, since these patient present severe hearing impairment at both ears. A considerable part of them might present vestibular deterioration as well. It is the purpose to detect possible presence of these SCC lesions on CT and MR in this population and the prevalence of these lesions compared to DFNA9 patients.
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: video nystagmographycandidates for cochlear implantation 18 years or older, who are eligible for implantation for the indication of bilateral severe hearing loss or single sided deafness. clinical audiometric and vestibular investigations, CT and MR imaging of petrous bone |
| control group | – | Diagnostic Test: video nystagmographySymptomatic DFNA9 patients carrying the p.P51S mutation in COCH, presenting the radiologic semicircular canal lesion(s) on CT and/or MR. clinical audiometric and vestibular investigations, CT and MR imaging of petrous bone |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- -all patients with severe hearing loss who are eligible for cochlear implantation who do not carry the p.P51S mutation in COCH and are at least 18 years of age
Key inclusion criteria (2 listed)
- must be eligible for cochlear implantation
- must be 18 years of age or older
Key exclusion criteria (3 listed)
- <18 years of age
- not eligible to undergo vestibular tests, especially videonystagmography
- contra-indication for MR or CT
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 |
|---|---|---|
| video nystagmographyAlso: video head impulse test, c & o VEMP (vestibular-evoked myogenic potentials), CT scan temporal bone, MR temporal boneroutine test battery applied to all cochlear implant candidates | Diagnostic test | control group, study group |
Primary outcome
CT/MR of SCC
Time frame: at time of recruitment
lesions to one or more semicircular canals on CT and/or MR of temporal bone
p.P51S
Time frame: at time of recruitment
carriers hip of p.P51S mutation in COCH
4 secondary outcomes
audiometry
Time frame: at time of recruitment
vestibular function 1
Time frame: at time of recruitment
vestibular function 2
Time frame: at time of recruitment
vestibular function 3
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 31 Mar 2022.
- 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 2 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 31 Mar 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 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/MR of SCC (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 31 Mar 2022.