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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]:
Participants will:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cochlear Implant | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | minimum 1 year post CI implantation procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Georgios Mantokoudis, MD | Contact | 316323321 | +41 | georgios.mantokoudis@insel.ch |
| Name | Affiliation | Role |
|---|---|---|
| Georgios Mantokoudis, MD | Inselgruppe AG | Principal Investigator |
| Thomas Sauter, MD | InselGruppe AG | Principal Investigator |
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| ID | Term |
|---|---|
| D000072458 | Orientation, Spatial |
| ID | Term |
|---|---|
| D013037 | Spatial Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D003054 | Cochlear Implants |
| ID | Term |
|---|---|
| D058117 | Neural Prostheses |
| D058542 | Implantable Neurostimulators |
| D004567 | Electrodes, Implanted |
| D004566 | Electrodes |
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| minimum 1 year post CI implantation procedure |
| D055615 |
| Electrical Equipment and Supplies |
| D004864 | Equipment and Supplies |
| D019736 | Prostheses and Implants |
| D006310 | Hearing Aids |
| D012682 | Sensory Aids |