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NCT Number: NCT03745560

Intraoperative EABR for Decision Making

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.

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Key information

Conditions

Vestibular Schwannoma Cranial Nerve Diseases Cranial Nerve Neoplasms Ear Diseases Hearing Disorders Hearing Loss Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Nerve Sheath Neoplasms Nervous System Diseases Nervous System Neoplasms Neurilemmoma Neuroectodermal Tumors Neuroendocrine Tumors Neurologic Manifestations Neuroma Neuroma, Acoustic Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pathological Conditions, Signs and Symptoms Peripheral Nervous System Neoplasms Retrocochlear Diseases Sensation Disorders Signs and Symptoms Vestibulocochlear Nerve Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Valerie Dahm

CONTACT

[email protected]

01/40400/33300

Sponsors and collaborators

Lead sponsor

Christoph Arnoldner

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2026
Study completion
2026
First posted
Nov 19, 2018
Registry last updated
Nov 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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