Study of Olfaction / Vision Interactions in Expert and Novice Populations

Healthy Clinical Trial

Official title:

Study of Olfaction / Vision Interactions in Expert and Novice Populations

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03058172
• Other study ID #: 69HCL16_0685
• Status: Recruiting
• Phase: N/A
• Start date: April 15, 2016
• Est. completion date: April 15, 2022

Study information

• Verified date: July 2021
• Source: Hospices Civils de Lyon
• Contact: Frédéric FAURE, MD
• Phone: 04 26 29 40 53
• Email: famillefaure[@]bbox.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this research project is to better understand the reciprocal influence of visual and olfactory systems on cerebral activity evoked by odors and visual stimuli. Given the importance of olfacto-visual learning in expert situations, the degree of expertise in olfaction will also be considered. In addition, the investigators will try to better understand the differences between expert and non-expert populations in olfaction through different levels of approach: sensory, genetic and cerebral. To achieve this, the investigators will use psychophysical tests, genetic analyzes and a non-invasive technique, functional magnetic resonance imaging (fMRI) to measure the brain activity of human subjects - novices or experts in olfaction - in response to different visual and olfactory stimuli.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: April 15, 2022
• Est. primary completion date: March 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• healthy volunteers

• men and women, aged 18-85 years old

• subjects with social security cover

• expertise in olfaction for half of the subjects (60)

Exclusion Criteria:

• subjects younger than 18 and older than 85

• subjects with contraindications to fMRI, i.e. with pacemaker / insulin pump / metal prosthesis / intracerebral clip / neurosensory stimulator / implantable defibrillator / cochlear implants / ferromagnetic ocular or cerebral foreign body close to the nerve structures / ventriculoperitoneal neurosurgical bypass valves / braces and other non-removable metallic dental device / claustrophobic, non-cooperating or agitated subjects.

• pregnant or breastfeeding women

• subjects with known olfactory disorder

• subjects with known neurological disorder

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Odor presentation (for participants' perception)
Several different odors will be diffused by an olfactometer under the participants' nostrils, though a controlled airflow, and synchronously with the participants' respiration. fMRI designs require repeated stimulus presentation. Odors will also be presented (in flasks or in odor pens) outside the scanner.
• Image presentation (for participants' perception)
Several different pictures will be displayed in front of the participants' face, though a through a mirror system in the scanner, or on a computer screen outside the scanner.

Locations

Country	Name	City	State
France	Infirmerie Protestante	Caluire et Cuire

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brain activity	fMRI 3T scanner in CERMEP imaging center (Bron - see web link at the end of the document), allowing anatomical measures, connectivity between olfactory and other regions (DTI), activation pattern in olfactory and visual areas.	During the 2-hour testing session (one session per participant)
Secondary	Genotyping	Genotyping from saliva samples by AMIS laboratory or a genotyping platform in Toulouse or Evry (see web links at the end of the document)	Sampling during the 2-hour testing session (one session per participant), analyses within 6 years after sampling
Secondary	Olfactory abilities	Threshold detection, discrimination between odorants and odor identification, measured with standardized olfactory tests	During the 2-hour testing session (one session per participant)
Secondary	Perception	Assesment of the perceptual profile of the stimulus on visual analogue scale (verbal report of how the olfactory/visual stimulus is perceived).	During the 2-hour testing session (one session per participant)
Secondary	Response times	Response time to the olfactory/visual stimulus in millisecond	During the 2-hour testing session (one session per participant)