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Intraoperative EABR for Decision Making

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03745560
Enrollment
15
Registered
2018-11-19
Start date
2017-05-23
Completion date
2026-05-23
Last updated
2024-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hearing Loss, Vestibular Schwannoma

Keywords

Cochlear implant

Brief 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.

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).

Interventions

None listed

Sponsors

Christoph Arnoldner
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Correlation of eABR results to postoperative hearing results2 yearseABR 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

Countries

Austria

Contacts

Primary ContactValerie Dahm
valerie.dahm@meduniwien.ac.at01/40400/33300

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026