CI Spatial Orientation Study (CISPACE)

April 1, 2026 updated by: Insel Gruppe AG, University Hospital Bern

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

700

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
minimum 1 year post CI implantation procedure.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
minimum 1 year post CI implantation procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Insel Gruppe AG, University Hospital Bern

Investigators

  • Principal Investigator: Georgios Mantokoudis, MD, InselGruppe AG
  • Principal Investigator: Thomas Sauter, MD, InselGruppe AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

December 1, 2029

Study Registration Dates

First Submitted

March 26, 2026

First Submitted That Met QC Criteria

April 1, 2026

First Posted (Actual)

April 3, 2026

Study Record Updates

Last Update Posted (Actual)

April 3, 2026

Last Update Submitted That Met QC Criteria

April 1, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-002123 CISPACE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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