CI Spatial Orientation Study
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInsel Gruppe AG, University Hospital Bern
About this trial
The goal of this clinical trial is to learn if cochlear implant activation affects spatial orientation in cochlear implant users. The main question\[s\] it aims to answer are\]:
* Does activation of the cochlear implant improve spatial orientation? * Is this improvement caused by better hearing ability through the cochlear implant?
Participants will:
* Take an online survey including questions about their cochlear implants and clinical questionnaires on dizziness and spatial orientation * Undergo balance and spatial orientation tests under different cochlear implant conditions.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
> 18 years
Ability to comply with study procedures
Use of a CI (unilateral or bilateral) for minimum 12 months
Signed, written informed consent
Disqualifiers
Vulnerable individuals
Cognitive impairment or altered mental status affecting participation
Physical conditions signficantly limiting mobility (e.g. severe gait or muscoskeletal disorders)
Trial design
Design model
Single group
Treatments tested in this trial
Cochlear Implant
DeviceThe intervention consists of temporary manipulation of the CI's settings in three separate conditions: Sound processor microphone on with spatial auditory cues provided by sound speakers, broadband noise stimulus to wireless microphone, CI off. Switching between conditions can be accomplished by manipulating the sound mixture between the two microphones (sound processor and wireless) by a standard app provided by the CI manufacturers.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Change in spatial orientation performance across three CI conditions as measured by the triangle completion task (TCT), rotational spatial orientation task(RSOT), and virtual spatial orientation task (VSOT).
A repeated measures ANOVA will be conducted for each of the three spatial orientation tasks to test the effect of CI condition on the following dependent variables:TCT - relative and absolute distance error, relative and absolute rotation error. RSOT - relative and absolute angular deviation. VSOT - navigation efficiency, relative time deviation, path length
Time frame
minimum 1 year post CI implantation procedure.Secondary outcomes
1
Point Prevalence of Spatial Orientation Disorders in Cochlear Implant Users
Assessed via two study-specific screening questions and the Santa Barbara Sense of Direction questionnaire. Descriptive statistics will be used to calculate the proportion of participants meeting the criteria for spatial orientation difficulties. The prevalence estimate will be accompanied by a 95% confidence interval to quantify statistical precision.
Time frame
minimum 1 year post CI implantation procedureLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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