Cochlear Implants, Spatial Orientation
Conditions
Brief summary
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.
Interventions
DEVICECochlear Implant
The 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.
Sponsors
Insel Gruppe AG, University Hospital Bern
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* \> 18 years * Ability to comply with study procedures * Use of a CI (unilateral or bilateral) for minimum 12 months * Signed, written informed consent
Exclusion criteria
* Vulnerable individuals * Cognitive impairment or altered mental status affecting participation * Physical conditions signficantly limiting mobility (e.g. severe gait or muscoskeletal disorders)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). | minimum 1 year post CI implantation procedure. | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Point Prevalence of Spatial Orientation Disorders in Cochlear Implant Users | minimum 1 year post CI implantation procedure | 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. |
Contacts
CONTACTGeorgios Mantokoudis, MD
PRINCIPAL_INVESTIGATORGeorgios Mantokoudis, MD
Inselgruppe AG
PRINCIPAL_INVESTIGATORThomas Sauter, MD
InselGruppe AG
Outcome results
None listed