Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05547113 |
| Other study ID # |
323721 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 11, 2020 |
| Est. completion date |
May 2024 |
Study information
| Verified date |
February 2024 |
| Source |
Charles University, Czech Republic |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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. 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.
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.
