CClinicalTrials.gg
CompletedNCT05795530Updated Feb 9, 2024

Vestibular Function in Cochlear Implants

An observational study in Cochlear Trauma, Vestibular Disorder and Deafness, Bilateral, sponsored by Charles University, Czech Republic. Completed at 1 site in Czechia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-09.

Sponsored by Charles University, Czech Republic · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
57
Ages
18 Years and older
Sex
All
01

Study summary

The objective of this study is to identify possible preoperative risk factors including genetic background and to suggest the optimal test battery of vestibular function in cochlear implant recipients

Read the detailed description

The objective of this study is to identify possible preoperative risk factors including genetic background and to suggest the optimal test battery of vestibular function in cochlear implant recipients Participants underwent standard vestibular testing including video head impulse test (vHIT), vestibular evoked myogenic potentials (VEMP), subjective visual vertical and stabilometry before and after the surgery.

02

Conditions studied

  • Cochlear Trauma
  • Vestibular Disorder
  • Deafness, Bilateral

Keywords

  • cochlear implant
03

In context

Deafness

609 studies on the registry are indexed under Deafness; 111 are open to participants now.

This study's enrollment of 57 is below the median of 80 across 168 observational studies indexed under Deafness.

Browse Deafness studies →

Lead sponsor

Charles University, Czech Republic is the lead sponsor of 220 studies on the registry; 76 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Probability sample

Study population

57 adult CI recipients The indication for surgery was hearing impairment. Round window approach was used preferably for insertion of the electrode array. Anamestic data as a history of hearing impairment, family history and the use of hearing aids were collected from all the patients.

They underwent routine vestibular testing before and after the intervention.

Inclusion criteria

  • profound bilateral sensorineural hearing loss meeting criteria for cochlear implantation

Exclusion criteria

Exclusion Criteria:

  • profound unilateral sensorineural hearing loss meeting criteria for cochlear implantation
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
57 participants (actual)
Patient registry
No

Groups and cohorts

  • Cochlear implant recipients

    57 consecutive cochlear implant recipients

    Procedure: cochlear implantation

Interventions

  • Procedurecochlear implantation

    surgery for bilateral hearing loss

06

What researchers measure

Primary outcomes

  1. vestibular function

    semicircular canal function measured by vHIT

    Time frame: from 2 days before the intervention to 3 weeks after the intervention

  2. vestibular function

    otolith function measured by VEMP

    Time frame: from 2 days before the intervention to 3 weeks after the intervention

  3. postural function

    postural function and stability measured by stabilometry

    Time frame: from 2 days before the intervention to 3 weeks after the intervention

07

Study locations

1 site
  • Department of Otorhinolaryngology and Head and Neck Surgery, 1st Faculty of Medicine Charles University and Motol University Hospital, Postgraduate Medical School
    Prague, 15006, Czechia
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05795530
Lead sponsor
Charles University, Czech Republic
Responsible party
Marketa Bonaventurova (Principle Investigator, Charles University, Czech Republic) — Principal investigator
First posted
Apr 3, 2023
Start date
Oct 1, 2018
Primary completion
Mar 1, 2020
Completion
Jun 30, 2020
Last update
Feb 9, 2024

Study contacts

Zuzana Balatkova
study chair · Dept Of ENT, 1st Faculty Of Medicine, University Hospital Motol

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion