- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05547113
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
Recruiting
Conditions
Intervention / Treatment
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
Observational
Enrollment (Estimated)
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
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Czech Republic
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Praha, Czech Republic, Czechia, 15006
- Recruiting
- Department of Rehabilitation and Sports Medicine, 2nd Medical Faculty, Charles University and University Hospital Motol
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Contact:
- Ondrej Cakrt, doc.
- Phone Number: +420732635224
- Email: ondrej.cakrt@lfmotol.cuni.cz
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Principal Investigator:
- Sara Koutna, Mgr
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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
Ages Eligible for Study
16 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 |
Intervention / Treatment |
---|---|
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.
|
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:
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What is the study measuring?
Primary Outcome Measures
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
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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
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.
Collaborators
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)
January 11, 2020
Primary Completion (Estimated)
March 1, 2024
Study Completion (Estimated)
May 1, 2024
Study Registration Dates
First Submitted
August 31, 2022
First Submitted That Met QC Criteria
September 15, 2022
First Posted (Actual)
September 21, 2022
Study Record Updates
Last Update Posted (Actual)
February 8, 2024
Last Update Submitted That Met QC Criteria
February 7, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Other Study ID 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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