Vestibular Function in Cochlear Implants

Completed

• Conditions: Deafness, Bilateral; Cochlear Trauma; Vestibular Disorder
• Interventions: Procedure: cochlear implantation

• Registration Number: NCT05795530
• Lead Sponsor: Charles University, Czech Republic

Brief 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

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.

Study Timeline

• Study Start: 2018-10-01
• Primary Completion: 2020-03-01
• Study Completion: 2020-06-30
• Study First Submitted: 2023-03-21
• Study First Submitted QC: 2023-03-21
• Study First Posted: 2023-04-03
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-07
• Last Update Posted: 2024-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

Inclusion Criteria

• profound bilateral sensorineural hearing loss meeting criteria for cochlear implantation

Exclusion Criteria

• profound unilateral sensorineural hearing loss meeting criteria for cochlear implantation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cochlear implant recipients	cochlear implantation	57 consecutive cochlear implant recipients

Primary Outcome Measures

Name	Time	Method
vestibular function	from 2 days before the intervention to 3 weeks after the intervention	otolith function measured by VEMP
postural function	from 2 days before the intervention to 3 weeks after the intervention	postural function and stability measured by stabilometry

Trial Locations

Locations (1)

Department of Otorhinolaryngology and Head and Neck Surgery, 1st Faculty of Medicine Charles University and Motol University Hospital, Postgraduate Medical School; 🇨🇿 Prague, Czechia