- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05308433
Cybersickness imAgiNg Olfactory Evocation (CANOE)
November 4, 2022 updated by: Cécile RUMEAU, Central Hospital, Nancy, France
The aim of this study is to, using fMRI, compare brain activations during olfactory imagery induced by different visual supports (words, pictures, colors and colored arrangements) in healthy subjects.
This will allow us to choose the best olfactory imagery facilitator and to assess its effect on cybersickness.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
30
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 Locations
-
-
-
Nancy, France
- CHRU Nancy
-
-
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
18 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- to be of French nationality who has always lived in metropolitan France;
- to be right-handed person;
- to be enrolled in a social security plan;
- to be able to understand the instructions given;
- to have underwent a pre-inclusion medical examination;
- to give a written consent;
- Person with a strong capacity for olfactory imagination: having obtained a score strictly below 2.5 on the fVOIQ olfactory imagination questionnaire.
Exclusion Criteria:
- to have an inability to read French;
- to be recognized as a synesthete;
- to have a professional activity requires intense olfactory activity;
- to have a partial or total loss of smell (hyposmia, anosmia);
- to have qualitative smell disorders (carcosomia, hyperosmia, phantosmia, parosmia);
- to have smell disorders of neurological, post-traumatic or neurodegenerative origin;
- to have uncorrected or poorly corrected visual disturbances;
- to have vestibular disorder diagnosed;
- any contraindication to MR examination (active medical device, ferromagnetic foreign body, pregnancy, morbid obesity, claustrophobia, … );
- subject under a measure of legal protection.
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: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental
|
The volunteer will have to imagine the smells evoked by different visual aids.
This task will be carried out during 2 acquisition runs of about 10 minutes each.
The volunteer should note (on a scale from 1 to 4) the pleasantness of the smell evoked.
Other Names:
The volunteer will be immersed in a virtual maritime environment with nauseating characteristics.
In the center of the maritime scene, it will be visible the black outlines of a frame.
Every minute, the volunteer will be asked to verbalize the level of his general condition via the Fast Motion Sickness Scale (1 to 20).
Other Names:
The volunteer will be immersed in a virtual maritime environment with nauseating characteristics.
The visual support inserted in the center of the virtual scene will be the one defined as being the most facilitator of the olfactory imagination during the fMRI examination.
The volunteer will be asked to concentrate on the smell evoked by this support.
Every minute, the volunteer will be asked to verbalize the level of his general condition via the Fast Motion Sickness Scale (1 to 20).
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparison of cerebral activations between the different supports mediating the olfactory imagination during the execution of the fMRI tasks.
Time Frame: Baseline (J0)
|
The cerebral activations between the different supports mediating the olfactory imagination will be compared in terms of localization and intensity of the variations of the BOLD signal during the execution of the fMRI tasks.
|
Baseline (J0)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Determination of the visual support allowing the strongest olfactory imagination during the fMRI by subjective evaluations using two 4-level Likert scales.
Time Frame: Baseline (J0)
|
Subjective evaluations will be carried out using two 4-level Likert scales.
|
Baseline (J0)
|
Determination of the visual support allowing the strongest olfactory imagination during the fMRI test by the cerebral activations in areas recognized for their implications in the olfactory imagination.
Time Frame: Baseline (J0)
|
The cerebral activations will be measured by the intensity of the variations of the BOLD signal during the execution of the fMRI tasks.
|
Baseline (J0)
|
Description of the evolution of the cardiac activity during olfactory imagination tasks in fMRI.
Time Frame: Baseline (J0)
|
The cardiac activity will be evaluated by the R-wave interval.
The cardiac activity will be recorded via the ECG during olfactory imagination tasks in fMRI.
|
Baseline (J0)
|
Description of the evolution of the respiratory activity during olfactory imagination tasks in fMRI.
Time Frame: Baseline (J0)
|
The respiratory activity will be evaluated by the respiratory rate.
The respiratory activity will be recorded via the respiratory belt during olfactory imagination tasks in fMRI.
|
Baseline (J0)
|
Evaluation of the state of discomfort in virtual reality by measuring the cardiac activity.
Time Frame: Baseline (J0) and 6 months maximum after J0 (V1)
|
Cardiac activity will be evaluated by the R-wave interval.
Cardiac activity during immersion will be recorded by the cardio-respiratory belt.
|
Baseline (J0) and 6 months maximum after J0 (V1)
|
Evaluation of the state of discomfort in virtual reality by the "Simulator Sickness Questionnaire" (SSQ) before and after immersion.
Time Frame: Baseline (J0) and 6 months maximum after J0 (V1)
|
The participant will answer to the "Simulator Sickness Questionnaire" (SSQ) before and after immersion (minimum=0 and maximum=235,62).
A higher score means a more severe discomfort.
|
Baseline (J0) and 6 months maximum after J0 (V1)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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 (Actual)
April 13, 2022
Primary Completion (Actual)
July 12, 2022
Study Completion (Actual)
October 26, 2022
Study Registration Dates
First Submitted
March 4, 2022
First Submitted That Met QC Criteria
March 24, 2022
First Posted (Actual)
April 4, 2022
Study Record Updates
Last Update Posted (Actual)
November 7, 2022
Last Update Submitted That Met QC Criteria
November 4, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2021-A02854-37
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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