Intraoperative EABR for Decision Making

September 25, 2021 updated by: Christoph Arnoldner

Simultaneous Translabyrinthine Surgery of Vestibular Schwannoma and Cochlear Implantation With Intraoperative eBERA and Correlation to Hearing Results - a Pilot Study

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.

Study Overview

Status

Recruiting

Conditions

Detailed 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).

Study Type

Observational

Enrollment (Anticipated)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Recruiting
        • AKH, MUW

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing translabyrinthine vestibular schwannoma resection and cochlear implantation

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of eABR results to postoperative hearing results
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
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Christoph Arnoldner

Investigators

  • Principal Investigator: Christoph Arnoldner, MD, MUW, Allgemeines Krankenhaus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 23, 2017

Primary Completion (Anticipated)

May 23, 2022

Study Completion (Anticipated)

May 23, 2023

Study Registration Dates

First Submitted

November 3, 2018

First Submitted That Met QC Criteria

November 16, 2018

First Posted (Actual)

November 19, 2018

Study Record Updates

Last Update Posted (Actual)

September 28, 2021

Last Update Submitted That Met QC Criteria

September 25, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1111/2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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