Intraoperative EABR for Decision Making

NCT03745560 | Recruiting

• 1 other identifier: 1111/2017
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Vestibular Schwannoma; Hearing Loss

Keywords

Cochlear implant

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing translabyrinthine vestibular schwannoma resection and cochlear implantation

You may qualify if:

• Patients between 18 and 99 years undergoing translabyrinthine vestibular schwannoma resection
• Patients wanted hearing rehabilitation with a cochlear implant

You may not qualify if:

• patients who do not want to be part of the study

Sponsors & Collaborators

• Christoph Arnoldner: lead

Study Sites (1)

AKH, MUW

Vienna, Austria, 1090, Austria

RECRUITING

Related Publications (1)

• Gadenstaetter AJ, Auinger AB, Gerlitz M, Riss D, Yildiz E, Roessler K, Matula C, Dahm V, Arnoldner C. Long-Term Follow-Up After Translabyrinthine IAC Tumor Removal With Simultaneous Cochlear Implantation. Otol Neurotol. 2025 Dec 1;46(10):1310-1315. doi: 10.1097/MAO.0000000000004313. Epub 2025 Nov 12.

  PMID: 39284021 DERIVED

MeSH Terms

Conditions

Neuroma, Acoustic; Hearing Loss

Condition Hierarchy (Ancestors)

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

Study Officials

• Christoph Arnoldner, MD

  MUW, Allgemeines Krankenhaus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Valerie Dahm

CONTACT

01/40400/33300; valerie.dahm@meduniwien.ac.at

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assoc. Prof PD. Dr.

Study Record Dates

• First Submitted: November 3, 2018
• First Posted: November 19, 2018
• Study Start: May 23, 2017
• Primary Completion (Estimated): May 23, 2026
• Study Completion (Estimated): May 23, 2026
• Last Updated: November 25, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)