Cochlear ImplantationNCT05547113
Vestibular Function in Cochlear Implant Patients
An observational study of Cochlear Implantation, run by Charles University, Czech Republic at 1 site in Czechia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cochlear Implantation
- What is being tested?
- posturography
- How many people
- 40 participants
- Where
- 1 siteCzechia
- Study dates
- 11 Jan 2020to May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: working age candidates who are coming for cochlear implantation from all of the country
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
Department of Rehabilitation and Sports Medicine, 2nd Medical Faculty, Charles University and University Hospital Motol
Prague, Czech Republic, 15006
Ondrej Cakrt, doc., +420732635224, ondrej.cakrt@lfmotol.cuni.cz
Sara Koutna, Mgr
About this study
Official title: 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.
Read the 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.
- Conditions
- Cochlear Implantation
- Being tested
- posturography
- Keywords
- vestibular function, cochlear implantation, postural stability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
posturographyDiagnostic test
Also called subjective visual vertical, questionnaires
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: posturography |
What is being measured
The primary outcome is the main question the study is designed to answer.
In patients with the cochlear implant there are changes in the function of the vestibular system, specifically in sway path.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: Pre operative - baseline, than 1st day after surgery, 2-3 weeks after surgery and than at least 6 months after the surgery
Secondary outcomes (1)
In patients with the cochlear implant there are changes in the function of the vestibular system, specifically in the subjective visual vertical.
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.
Measured: Pre operative - baseline, than 1st day after surgery, 2-3 weeks after surgery and than at least 6 months after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2022
- Study start11 Jan 2020
- Primary completionMar 2024 (estimated)
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cochlear ImplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Motol
- Responsible party
- Principal investigator, Sara Koutna, Charles University, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05547113
- Sponsor's protocol ID
- 323721
- Status last verified
- Feb 2024
- First submitted
- 31 Aug 2022
- Last updated
- 8 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Koutna S, Kalitova P, Jerabek J, Slaby K, Kucerova K, Boucek J, Cakrt O. Comparison of postural control and space perception outcomes between robotic and conventional cochlear implantation in adults. Eur Arch Otorhinolaryngol. 2024 Jul;281(7):3839-3843. doi: 10.1007/s00405-024-08664-3. Epub 2024 Jun 2.
PubMed 38825603
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vestibular Function and Quality of Life in Patients After Cochlear Implantation
- ClinicalTrials.gov ID
- NCT05547113
- Acronym / sponsor ID
- 323721
- Conditions
- Cochlear Implantation
- Keywords
- vestibular function, cochlear implantation, postural stability
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Collaborators
- University Hospital, Motol
- Study start
- 11 Jan 2020 (actual)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 21 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cochlear implant patients | – | Diagnostic Test: posturographyThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- working age candidates who are coming for cochlear implantation from all of the country
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| posturographyAlso: subjective visual vertical, questionnairesIn 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. | Diagnostic test | Cochlear implant patients |
Primary outcome
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.
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.
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.
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
- Derived from this study: PubMed 38825603Koutna S, Kalitova P, Jerabek J, Slaby K, Kucerova K, Boucek J, Cakrt O. Comparison of postural control and space perception outcomes between robotic and conventional cochlear implantation in adults. Eur Arch Otorhinolaryngol. 2024 Jul;281(7):3839-3843. doi: 10.1007/s00405-024-08664-3. Epub 2024 Jun 2.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Department of Rehabilitation and Sports Medicine, 2nd Medical Faculty, Charles University and University Hospital Motol
Prague, Czechia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cochlear Implantation, run by Charles University, Czech Republic at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05547113, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2024.