Vestibular Function in Cochlear Implants

NCT05795530 | Completed

• 1 other identifier: CharlesUCZ
• Study Type: observational
• Target: 57
• Locations: 1 country
• Sites: 1

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

Conditions

Cochlear Trauma; Vestibular Disorder; Deafness, Bilateral

Keywords

cochlear implant

Outcome Measures

Primary Outcomes (3)

• vestibular function

  semicircular canal function measured by vHIT

  from 2 days before the intervention to 3 weeks after the intervention

• vestibular function

  otolith function measured by VEMP

  from 2 days before the intervention to 3 weeks after the intervention

• postural function

  postural function and stability measured by stabilometry

  from 2 days before the intervention to 3 weeks after the intervention

Study Arms (1)

Cochlear implant recipients

57 consecutive cochlear implant recipients

Procedure: cochlear implantation

Interventions

cochlear implantation PROCEDURE

surgery for bilateral hearing loss

Cochlear implant recipients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• profound bilateral sensorineural hearing loss meeting criteria for cochlear implantation

You may not qualify if:

• profound unilateral sensorineural hearing loss meeting criteria for cochlear implantation

Sponsors & Collaborators

• Charles University, Czech Republic: lead

Study Sites (1)

Department of Otorhinolaryngology and Head and Neck Surgery, 1st Faculty of Medicine Charles University and Motol University Hospital, Postgraduate Medical School

Prague, 15006, Czechia

Location

MeSH Terms

Conditions

Vestibular Diseases; Hearing Loss, Bilateral

Interventions

Cochlear Implantation

Condition Hierarchy (Ancestors)

Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Hearing Loss; Hearing Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Otologic Surgical Procedures; Otorhinolaryngologic Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation

Study Officials

• Zuzana Balatkova

  Dept Of ENT, 1st Faculty Of Medicine, University Hospital Motol

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: March 21, 2023
• First Posted: April 3, 2023
• Study Start: October 1, 2018
• Primary Completion: March 1, 2020
• Study Completion: June 30, 2020
• Last Updated: February 9, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)