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NCT03745534 Clinical Trial

Cochlear Implantation After Gamma Knife Radiosurgery With eABR and Correlation to Postoperative Hearing Results - a Pilot Study

Hearing Loss Clinical Trial

Official title:
Cochlear Implantation After Gamma Knife Radiosurgery With eABR and Correlation to Postoperative Hearing Results - a Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data
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

Study information
Verified date December 2020
Source Medical University of Vienna
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.

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.

Recruitment information / eligibility
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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• eABR
eABR

Locations
Country Name City State
Austria AKH; MUW Vienna

Sponsors (1)
Lead Sponsor Collaborator
Christoph Arnoldner

Country where clinical trial is conducted

Austria, 

Outcome
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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