CI Spatial Orientation Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cochlear Implant.
- Who it may be relevant to
- Registry conditions: Cochlear Implants, Spatial Orientation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Effect of Cochlear Implant Stimulation on Spatial Orientation in Adult Users
Overview
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
- Device Cochlear 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.
Primary outcome measures
- 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.]
Secondary outcome measures (1)
- Point Prevalence of Spatial Orientation Disorders in Cochlear Implant Users [Time frame: minimum 1 year post CI implantation procedure]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07510659 · 2025-002123 CISPACE