Vestibular Function in Cochlear Implants | NCT05795530

Studies
Vestibular Function in Cochlear Implants

NCT05795530

Sponsor

Charles University, Czech Republic

Status

Completed

Last Update Posted

Feb 9, 2024Actual

Enrollment

57Actual

Phase

Not provided

Conditions

Cochlear Trauma
Vestibular Disorder
Deafness, Bilateral

Interventions

cochlear implantation

Countries

Czechia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2018Actual

Primary Completion Date

Mar 1, 2020Actual

Completion Date

Jun 30, 2020Actual

First Submitted Date

Mar 21, 2023

First Submission Date that Met QC Criteria

Mar 21, 2023

First Posted Date

Apr 3, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 7, 2024

Last Update Posted Date

Feb 9, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Marketa Bonaventurova, Principle Investigator, Charles University, Czech RepublicPrincipal Investigator

Lead Sponsor

Charles University, Czech RepublicOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

57Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cochlear implant recipients		57 consecutive cochlear implant recipients	Procedure: cochlear implantation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
cochlear implantation	Procedure	surgery for bilateral hearing loss	Cochlear implant recipients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

profound bilateral sensorineural hearing loss meeting criteria for cochlear implantation

Exclusion Criteria:

profound unilateral sensorineural hearing loss meeting criteria for cochlear implantation

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Zuzana Balatkova	Dept Of ENT, 1st Faculty Of Medicine, University Hospital Motol	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Otorhinolaryngology and Head and Neck Surgery, 1st Faculty of Medicine Charles University and Motol University Hospital, Postgraduate Medical School		Prague		15006	Czechia

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015837	Vestibular Diseases
D006312	Hearing Loss, Bilateral

Ancestor Terms

ID	Term
D007759	Labyrinth Diseases
D004427	Ear Diseases
D010038	Otorhinolaryngologic Diseases
D034381	Hearing Loss

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019929	Cochlear Implantation

Ancestor Terms

ID	Term
D013506	Otologic Surgical Procedures
D013517	Otorhinolaryngologic Surgical Procedures
D013514	Surgical Procedures, Operative
D019919	Prosthesis Implantation

Browse Leaves

Not provided

Browse Branches

Not provided