Hearing Loss Clinical Trial
Official title:
Cochlear Implantation After Gamma Knife Radiosurgery With eABR and Correlation to Postoperative Hearing Results - a Pilot Study
NCT number | NCT03745534 |
Other study ID # | 1564/2018 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | August 1, 2018 |
Est. completion date | June 30, 2023 |
Verified date | December 2020 |
Source | Medical University of Vienna |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Recruiting |
Enrollment | 8 |
Est. completion date | June 30, 2023 |
Est. primary completion date | July 31, 2022 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients who have undergone radio surgery for vestibular schwannoma - Patients wanting cochlear implantation for hearing rehabilitation Exclusion Criteria: - Patients not wanting to participate in the study |
Country | Name | City | State |
---|---|---|---|
Austria | AKH; MUW | Vienna |
Lead Sponsor | Collaborator |
---|---|
Christoph Arnoldner |
Austria,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 2 years |
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