Cochlear ImplantsCISPACENCT07510659
CI Spatial Orientation Study
A study testing Cochlear Implant in people with Cochlear Implants and Spatial Orientation, run by Insel Gruppe AG, University Hospital Bern.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cochlear Implants, Spatial Orientation
- What is being tested?
- Cochlear Implant
- Type of treatment
- Medical device
- How many people
- 700 participants
- Where
- No sites listed yet
- Study dates
- Apr 2026to Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- > 18 years
- Ability to comply with study procedures
- Use of a CI (unilateral or bilateral) for minimum 12 months
- Signed, written informed consent
Who cannot join
- Vulnerable individuals
- Cognitive impairment or altered mental status affecting participation
- Physical conditions signficantly limiting mobility (e.g. severe gait or muscoskeletal disorders)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Cochlear Implant Stimulation on Spatial Orientation in Adult Users
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.
- Conditions
- Cochlear Implants, Spatial Orientation
- Being tested
- Cochlear Implant
- Medical subject headings
- Orientation, Spatial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cochlear ImplantDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: minimum 1 year post CI implantation procedure.
Secondary outcomes (1)
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.
Measured: minimum 1 year post CI implantation procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2026
- Study startApr 2026 (estimated)
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cochlear ImplantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Georgios Mantokoudis, MD, Principal investigator, Inselgruppe AGThomas Sauter, MD, Principal investigator, InselGruppe AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07510659
- Sponsor's protocol ID
- 2025-002123 CISPACE
- Other IDs
- 2025
- Acronym
- CISPACE
- Status last verified
- Apr 2026
- First submitted
- 26 Mar 2026
- Last updated
- 3 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cochlear Implant Stimulation on Spatial Orientation in Adult Users
- ClinicalTrials.gov ID
- NCT07510659
- Acronym / sponsor ID
- CISPACE / 2025-002123 CISPACE
- Conditions
- Cochlear Implants, Spatial Orientation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 3 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- > 18 years
- Ability to comply with study procedures
- Use of a CI (unilateral or bilateral) for minimum 12 months
- Signed, written informed consent
Key exclusion criteria (3 listed)
- Vulnerable individuals
- Cognitive impairment or altered mental status affecting participation
- Physical conditions signficantly limiting mobility (e.g. severe gait or muscoskeletal disorders)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cochlear ImplantThe 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. | Device | – |
Primary outcome
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
1 secondary outcome
Point Prevalence of Spatial Orientation Disorders in Cochlear Implant Users
Time frame: minimum 1 year post CI implantation procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Georgios Mantokoudis, MD principal investigator
Inselgruppe AG
Thomas Sauter, MD principal investigator
InselGruppe AG
Questions about this trial
What is this clinical trial studying?
A study testing Cochlear Implant in people with Cochlear Implants and Spatial Orientation, run by Insel Gruppe AG, University Hospital Bern.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Georgios Mantokoudis, MD (316323321 ext. +41, georgios.mantokoudis@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.