CClinicalTrials.gg
Not yet recruitingNCT07510659CISPACEUpdated Apr 3, 2026

CI Spatial Orientation Study

An interventional study of Cochlear Implant in Cochlear Implants and Spatial Orientation, sponsored by Insel Gruppe AG, University Hospital Bern. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-03.

Sponsored by Insel Gruppe AG, University Hospital Bern · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
700
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.
02

Conditions studied

  • Cochlear Implants
  • Spatial Orientation
03

In context

Lead sponsor

Insel Gruppe AG, University Hospital Bern is the lead sponsor of 724 studies on the registry; 177 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • Vulnerable individuals
  • Cognitive impairment or altered mental status affecting participation
  • Physical conditions signficantly limiting mobility (e.g. severe gait or muscoskeletal disorders)
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
700 participants (estimated)

Interventions

  • DeviceCochlear 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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 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.

    Time frame: minimum 1 year post CI implantation procedure

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07510659
Lead sponsor
Insel Gruppe AG, University Hospital Bern
Responsible party
Sponsor
First posted
Apr 3, 2026
Start date
Apr 2026 (estimated)
Primary completion
Dec 2029 (estimated)
Completion
Dec 2029 (estimated)
Last update
Apr 3, 2026

Study contacts

Georgios Mantokoudis, MD
Contact
georgios.mantokoudis@insel.ch
316323321 ext. +41
Georgios Mantokoudis, MD
principal investigator · Inselgruppe AG
Thomas Sauter, MD
principal investigator · InselGruppe AG

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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