NCT03745534

Brief Summary

Patients undergoing cochlear implantation after radio surgery for vestibular schwannoma will be included in the study. Patients will undergo preoperative and intraoperative eABR measurement. Correlations to postoperative hearing results will be drawn.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for all trials

Timeline
5mo left

Started Aug 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
Aug 2018Oct 2026

Study Start

First participant enrolled

August 1, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 3, 2018

Completed
16 days until next milestone

First Posted

Study publicly available on registry

November 19, 2018

Completed
7.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2026

Last Updated

November 25, 2024

Status Verified

November 1, 2024

Enrollment Period

8 years

First QC Date

November 3, 2018

Last Update Submit

November 21, 2024

Conditions

Vestibular SchwannomaHearing Loss

Outcome Measures

Primary Outcomes (1)

  • eABR correlation

    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

Interventions

eABROTHER

eABR

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients after radio surgery for vestibular schwannoma undergoing cochlear implantation

You may qualify if:

  • Patients who have undergone radio surgery for vestibular schwannoma
  • Patients wanting cochlear implantation for hearing rehabilitation

You may not qualify if:

  • Patients not wanting to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AKH; MUW

Vienna, Vienna, 1090, Austria

RECRUITING

MeSH Terms

Conditions

Neuroma, AcousticHearing Loss

Condition Hierarchy (Ancestors)

NeurilemmomaNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeuromaNerve Sheath NeoplasmsNeoplasms, Nerve TissueCranial Nerve NeoplasmsNervous System NeoplasmsNeoplasms by SitePeripheral Nervous System NeoplasmsVestibulocochlear Nerve DiseasesRetrocochlear DiseasesEar DiseasesOtorhinolaryngologic DiseasesOtorhinolaryngologic NeoplasmsCranial Nerve DiseasesNervous System DiseasesHearing DisordersSensation DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
OTHER
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

August 1, 2018

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

October 30, 2026

Last Updated

November 25, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)