Vestibular SchwannomaNCT03745534
Cochlear Implantation After Gamma Knife Radiosurgery with EABR and Correlation to Postoperative Hearing Results - a Pilot Study
An observational study of Vestibular Schwannoma and Hearing Loss, run by Christoph Arnoldner at 1 site in Austria.
Trial summary
Patients undergoing cochlear implantation after radio surgery for vestibular schwannoma will be included in the study. Patients will undergo preoperative and intraoperative eABR measurement. Correlations to postoperative hearing results will be drawn. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vestibular Schwannoma, Hearing Loss
- What is being tested?
- eABR
- How many people
- 8 participants
- Where
- 1 siteAustria
- Study dates
- 1 Aug 2018to 30 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: Patients after radio surgery for vestibular schwannoma undergoing cochlear implantation
Who may be able to join
- Patients who have undergone radio surgery for vestibular schwannoma
- Patients wanting cochlear implantation for hearing rehabilitation
Who cannot join
- Patients not wanting to participate in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
AKH; MUW
Vienna, State of Vienna, 1090
Valerie Dahm, MD, 004314040033300, valerie.dahm@meduniwien.ac.at
About this study
Patients undergoing cochlear implantation after radio surgery for vestibular schwannoma will be included in the study. Patients will undergo preoperative and intraoperative eABR measurement. Correlations to postoperative hearing results will be drawn.
Read the detailed description
Patients treated with radio surgery for vestibular schwannoma often suffer from hearing loss. Especially when the contralateral side has progressive hearing loss assessment if cochlear implantation is feasible, should be carried out. Patients undergo extensive audiometric testing. Additionally, patients will undergo preoperative eABR. Intraoperatively eABR is carried out and cochlear implantation is performed. The eABR results will be correlated with postoperative hearing. EABR measurements are not part of the study. The results of eBAR will be categorized in three groups (good response, weak response and no response). The eABR results will then be correlated to speech understanding with cochlear implants measured with Freiburger monosyllables test.
- Conditions
- Vestibular Schwannoma, Hearing Loss
- Being tested
- eABR
- Medical subject headings
- Neuroma, Acoustic, Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eABROther
eABR
What is being measured
The primary outcome is the main question the study is designed to answer.
eABR correlation
eABR is correlated with postoperative hearing results eABR will be divided in three categories - good response, weak response, no response Hearing results will be measured with speech understanding in Freiburg monosyllables word test which is measured in % of monosyllables understanding at 65 and 80dB
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2018
- Study start1 Aug 2018
- Primary completion31 Jul 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 Vestibular SchwannomaStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Christoph Arnoldner
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Christoph Arnoldner, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03745534
- Sponsor's protocol ID
- 1564/2018
- Status last verified
- Nov 2024
- First submitted
- 3 Nov 2018
- Last updated
- 25 Nov 2024
- 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 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cochlear Implantation After Gamma Knife Radiosurgery with EABR and Correlation to Postoperative Hearing Results - a Pilot Study
- ClinicalTrials.gov ID
- NCT03745534
- Acronym / sponsor ID
- 1564/2018
- Conditions
- Vestibular Schwannoma, Hearing Loss
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Christoph ArnoldnerUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 19 Nov 2018 (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.
Patients undergoing cochlear implantation after radio surgery for vestibular schwannoma will be included in the study. Patients will undergo preoperative and intraoperative eABR measurement. Correlations to postoperative hearing results will be drawn.
Detailed description
Patients treated with radio surgery for vestibular schwannoma often suffer from hearing loss. Especially when the contralateral side has progressive hearing loss assessment if cochlear implantation is feasible, should be carried out. Patients undergo extensive audiometric testing. Additionally, patients will undergo preoperative eABR. Intraoperatively eABR is carried out and cochlear implantation is performed. The eABR results will be correlated with postoperative hearing. EABR measurements are not part of the study. The results of eBAR will be categorized in three groups (good response, weak response and no response). The eABR results will then be correlated to speech understanding with cochlear implants measured with Freiburger monosyllables test.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients after radio surgery for vestibular schwannoma undergoing cochlear implantation
Key inclusion criteria (2 listed)
- Patients who have undergone radio surgery for vestibular schwannoma
- Patients wanting cochlear implantation for hearing rehabilitation
Key exclusion criteria (1 listed)
- Patients not wanting to participate in the study
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 |
|---|---|---|
| eABReABR | Other | – |
Primary outcome
eABR correlation
Time frame: 2 years
eABR is correlated with postoperative hearing results eABR will be divided in three categories - good response, weak response, no response Hearing results will be measured with speech understanding in Freiburg monosyllables word test which is measured in % of monosyllables understanding at 65 and 80dB
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2024.
- 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.
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 Vestibular Schwannoma and Hearing Loss, run by Christoph Arnoldner at 1 site in Austria.
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 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: looking for participants now, as of the sponsor's last update on 25 Nov 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 Austria. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
eABR correlation (time frame: 2 years). 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 Nov 2024.