Vestibular Function in Cochlear Implant Patients

NCT05547113 | Recruiting

• 1 other identifier: 323721
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cochlear Implantation

Keywords

vestibular function; cochlear implantation; postural stability

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  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.

  Pre operative - baseline, than 1st day after surgery, 2-3 weeks after surgery and than at least 6 months after the surgery

Study Arms (1)

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

Interventions

posturography DIAGNOSTIC_TEST

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.

Also known as: subjective visual vertical, questionnaires

Cochlear implant patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charles University, Czech Republic: lead
• University Hospital, Motol: collaborator

Study Sites (1)

Department of Rehabilitation and Sports Medicine, 2nd Medical Faculty, Charles University and University Hospital Motol

Prague, Czech Republic, 15006, Czechia

RECRUITING

Related Publications (1)

• 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.

  PMID: 38825603 DERIVED

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 31, 2022
• First Posted: September 21, 2022
• Study Start: January 11, 2020
• Primary Completion: March 1, 2024
• Study Completion: May 1, 2024
• Last Updated: February 8, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share

Locations

CZ (1)