Cybersickness imAgiNg Olfactory Evocation

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Device: Functional MRI

• Registration Number: NCT05308433
• Lead Sponsor: Central Hospital, Nancy, France

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-04
• Study First Submitted QC: 2022-03-24
• Study First Posted: 2022-04-04
• Study Start: 2022-04-13
• Primary Completion: 2022-07-12
• Study Completion: 2022-10-26
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-04
• Last Update Posted: 2022-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental	Functional MRI	-

Primary Outcome Measures

Name	Time	Method
Comparison of cerebral activations between the different supports mediating the olfactory imagination during the execution of the fMRI tasks.	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.

Secondary Outcome Measures

Name	Time	Method
Description of the evolution of the cardiac activity during olfactory imagination tasks in fMRI.	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.
Determination of the visual support allowing the strongest olfactory imagination during the fMRI by subjective evaluations using two 4-level Likert scales.	Baseline (J0)	Subjective evaluations will be carried out using two 4-level Likert scales.
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.	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.
Description of the evolution of the respiratory activity during olfactory imagination tasks in fMRI.	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.
Evaluation of the state of discomfort in virtual reality by measuring the cardiac activity.	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.
Evaluation of the state of discomfort in virtual reality by the "Simulator Sickness Questionnaire" (SSQ) before and after immersion.	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.

Trial Locations

Locations (1)

CHRU Nancy; 🇫🇷 Nancy, France