CI Spatial Orientation Study

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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Key information

Conditions

Cochlear Implants Behavior Orientation, Spatial Spatial Behavior Spatial Orientation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

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).

Time frame: 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

Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Georgios Mantokoudis, MD

CONTACT

[email protected]

316323321 ext. +41

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Official study title

Effect of Cochlear Implant Stimulation on Spatial Orientation in Adult Users

Acronym: CISPACE

Important dates

Study start: 2026
Primary completion: 2029
Study completion: 2029
First posted: Apr 3, 2026
Registry last updated: Apr 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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