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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03745560
Other study ID # 1111/2017
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 23, 2017
Est. completion date May 23, 2023

Study information

Verified date September 2021
Source Medical University of Vienna
Contact Valerie Dahm
Phone 01/40400/33300
Email valerie.dahm@meduniwien.ac.at
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

In this study patients undergoing simultaneous translabyrinthine vestibular schwannoma resection and cochlear implantation are included. The goal of the study is to correlate the eABR results with postoperative hearing results.


Description:

Patients undergoing translabyrinthine vestibular schwannoma resection are included in the study. Preoperatively an eABR is carried out, as well as before and after tumor resection. Postoperatively patients are fitted with a cochlear implant as routinely carried out. The postoperative hearing results with cochlear implant are correlated to the eABR results. The study is an observational study since eABR measurements are not part of the study. A correlation between eABR results categorized in three groups (good response, weak response, no response) with monosyllable understanding with cochlear implant (measured with Freiburger monosyllables test).


Recruitment information / eligibility

Status Recruiting
Enrollment 15
Est. completion date May 23, 2023
Est. primary completion date May 23, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria: - Patients between 18 and 99 years undergoing translabyrinthine vestibular schwannoma resection - Patients wanted hearing rehabilitation with a cochlear implant Exclusion Criteria: - patients who do not want to be part of the study

Study Design


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 Correlation of eABR results to postoperative hearing results 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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