Vestibular Function in Cochlear Implant Patients

February 7, 2024 updated by: Sara Koutna, Charles University, Czech Republic

Vestibular Function and Quality of Life in Patients After Cochlear Implantation

A hearing loss is condition which significantly affects the quality of life. The prevalence of the hearing disorders is relatively high due to many conditions which may result in a deafness. In those cases where hearing aids are not a sufficient solution to these difficulties, cochlear implantation is the standard treatment. It has been more than 30 years since the first implantation in the Czech Republic. These days it is common surgical procedure for adults and even children and it replaces, at least in part, the function of the hair cells that are no longer able to stimulate the primary auditory neurons.. Recent studies have reported that cochlear implant does not affect only hearing, but also other functions of the inner ear - the vestibular system resulting in stability and spatial orientation. Postural control is provided by coordination of movement strategies and sensory functions. If one ore more of these components are compromised postural instability appears. Instability is one of the most common causes of reduced quality of life. The deaf are characterized by their compensatory mechanisms, where visual system dominates over somatosensory and vestibular. After the cochlear implantation the postural behavior and compensations are changing apparently. The investigators assume that these mechanisms can be affected by vestibular rehabilitation. The purpose of this projet, will be to evaluate whether electrical stimulation of the eighth cranial nerve also affects vestibular functions and determine if the stimulaton changes postural stability and created compensations.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The patient undergoes a comprehensive examination of posture, stability of standing in 10 different conditions, stability of standing with sound stimulation, visual vertical examination and evaluation of the current mental state and subjective perception of difficulties through a questionnaire survey. All will be repeated four times at regular intervals. The investigators examine the patient before the surgery, 1 day after the surgery, 2-3 weeks afer it when the surgeons expect a stabilization of the postoperative condition, and with a gap of at least 6 months after the surgery, when the patient has already completed the adjustment of the speech processor and the compensation has been already created. Standing stability will be evaluated for 30 s in 10 different conditions with eyes open/closed eyes, with or without the foam, in a neutral head position/with an extended head, in a supine standing position/in tandem. The examination room include audio technology for playing sound, thanks to which the examinators can also assess the influence of sound perception and cognitive processes on maintaining stability during the measurement. The investigators will perform the stimulation while standing without visual control on the foam in 6 different sound conditions. With the speech processor on and off, with the white noise, spoken words in Czech language, for the patient completly foreign language (Finnish, or Chinese) and focused listening (simulated dual tasking) with control question at the end of the stimulation. Another method will be the examination of the perception of the subjective visual vertical. This is considered as a sensitive tool to detect asymmetric function of the labyrinths. The testing is in sitting position and controlled by a joystick move a straight line projected on a widescreen 2 meters infront of the participant. The examination is in static and dynamic mode, when during the dynamic examination, optokinetic stimulation occurs, which makes difficult to determine the vertical position. Standardized questionnaires will be used to evaluate subjectively perceived difficulties, quality of life and occurrence of psychological problems related to postural instability and underwent surgery.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
    • Czech Republic
      • Praha, Czech Republic, Czechia, 15006
        • Recruiting
        • Department of Rehabilitation and Sports Medicine, 2nd Medical Faculty, Charles University and University Hospital Motol
        • Contact:
        • Principal Investigator:
          • Sara Koutna, Mgr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

working age candidates who are coming for cochlear implantation from all of the country

Description

Inclusion Criteria:

  • patients who meet the demanding indication criteria for cochlear implantation (include an ENT examination, audiometry, neurological examination, examination by a clinical speech therapist and by a psychologist and CT examination of the temporal bones) also meet the conditions for inclusion into the study

Exclusion Criteria:

  • the presence of diseases of the load-bearing joints of the limbs
  • the presence of diseases of peripheral nervous system or muscle disease
  • the presence of disease of vision which would make visual fixation impossible

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Crossover
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Cochlear implant patients
The group of patients will consist of 40 adult patients indicated for cochlear implantation at the Department of ENT and Head and Neck Surgery, 1st Faculty of Medicine and FN Motol. Patients who meet the indication criteria for implantation also meet the conditions for inclusion in the study, another criterias are absence of diseases of the bearing joints, absence of diseases peripheral nervous system or muscle disease and absence of disease vision that would prevent visual fixation.
Diagnostic test: posturography
In our stabilometric laboratory we use for the posturography two Kistler stabilometric platforms (type 5619A, Switzerland) along with MARS software (version 5.0, Switzerland). We use the SYNAPSIS Subjective Vertical device (version 1.3.2, France) to examine the perception of the subjective visual vertical. The patients should also full fill 5 questionnaires to subjective evaluation of non-vestibular symptoms within ADL and QoL, namely for difficulties related to dizziness, tinnitus, orofacial function disorders and the occurrence of anxiety and depression. For this purpose we use Dizziness Handicap Inventory, Tinnitus Handicap Inventory, Facial Disability Index, Beck's Anxiety Inventory and Beck's Depression Inventory.
Other Names:
  • questionnaires
  • subjective visual vertical

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
In patients with the cochlear implant there are changes in the function of the vestibular system, specifically in sway path.
Time Frame: Pre operative - baseline, than 1st day after surgery, 2-3 weeks after surgery and than at least 6 months after the surgery
Compare of the result parameters from posturography as the sway path in mm in total, AP and ML directions. Testing before (baseline) and after the surgery in the same patient.
Pre operative - baseline, than 1st day after surgery, 2-3 weeks after surgery and than at least 6 months after the surgery
In patients with the cochlear implant there are changes in the function of the vestibular system, specifically in sway area.
Time Frame: Pre operative - baseline, than 1st day after surgery, 2-3 weeks after surgery and than at least 6 months after the surgery
Compare of the result parameters from posturography as the sway area in mm*2 in total, AP and ML directions. Testing it before (baseline) and after the surgery in the same patient.
Pre operative - baseline, than 1st day after surgery, 2-3 weeks after surgery and than at least 6 months after the surgery
In patients with the cochlear implant there are changes in the function of the vestibular system, specifically in the sway velocity.
Time Frame: Pre operative - baseline, than 1st day after surgery, 2-3 weeks after surgery and than at least 6 months after the surgery
Compare of the result parameters from posturography as the sway velocity in m/s in total, AP and ML directions. Testing before (baseline) and after the surgery in the same patient.
Pre operative - baseline, than 1st day after surgery, 2-3 weeks after surgery and than at least 6 months after the surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
In patients with the cochlear implant there are changes in the function of the vestibular system, specifically in the subjective visual vertical.
Time Frame: Pre operative - baseline, than 1st day after surgery, 2-3 weeks after surgery and than at least 6 months after the surgery
Evaluate the measurement of subjective visual vertical in angular degrees. If it follows the normal values or if the deviation from vertical is higher than 2°. Testing before (baseline) and after the surgery in the same patient.
Pre operative - baseline, than 1st day after surgery, 2-3 weeks after surgery and than at least 6 months after the surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Charles University, Czech Republic

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University Hospital, Motol

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 11, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 31, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 15, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 21, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 8, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 323721

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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