Intraoperative EABR for Decision Making

Hearing Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03745560
• Other study ID #: 1111/2017
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Hearing Loss
• Neurilemmoma
• Neuroma, Acoustic
• Vestibular Schwannoma

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