CI Spatial Orientation Study

NCT07510659 — Not applicable, Not yet recruiting, 700 participants, Insel Gruppe AG, University Hospital Bern

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Effect of Cochlear Implant Stimulation on Spatial Orientation in Adult Users

Registry	NCT07510659, acronym CISPACE
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, basic science
Enrollment	700 (Estimated)
Sponsor	Insel Gruppe AG, University Hospital Bern (Other)
Conditions	Cochlear Implants, Spatial Orientation
Interventions	Cochlear Implant (Device)
Dates	start 2026-04-01 (estimated), primary completion 2029-12-01 (estimated), completion 2029-12-01 (estimated), first posted 2026-04-03, last updated 2026-04-03

-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.

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+Arms and interventions

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.

+Outcome measures

Primary outcomes

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 outcomes

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.

+Eligibility

Sex: All, ages: 18 Years to any, accepts healthy volunteers

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)

+Investigators

Georgios Mantokoudis, MD, Principal investigator, Inselgruppe AG
Thomas Sauter, MD, Principal investigator, InselGruppe AG

+Funding

NIH grants: 2025