- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03058172
Study of Olfaction / Vision Interactions in Expert and Novice Populations
July 20, 2021 updated by: Hospices Civils de Lyon
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.
Study Overview
Status
Recruiting
Conditions
Study Type
Interventional
Enrollment (Anticipated)
120
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
- Name: Frédéric FAURE, MD
- Phone Number: 04 26 29 40 53
- Email: famillefaure@bbox.fr
Study Contact Backup
- Name: Moustafa BENSAFI, PhD
- Phone Number: 04 37 28 74 97
- Email: moustafa.bensafi@cnrs.fr
Study Locations
-
-
-
Caluire et Cuire, France, 69300
- Recruiting
- Infirmerie Protestante
-
Contact:
- Frédéric FAURE, MD
- Phone Number: 04 26 29 40 53
- Email: famillefaure@bbox.fr
-
-
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 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
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: Non-Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Odors (food and non-food)
Odorants diluted in mineral oil.
|
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.
|
Other: Pictures (food and non-food)
Pictures of objects or scenes.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Brain activity
Time Frame: During the 2-hour testing session (one session per participant)
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Genotyping
Time Frame: Sampling during the 2-hour testing session (one session per participant), analyses within 6 years after sampling
|
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
|
Olfactory abilities
Time Frame: During the 2-hour testing session (one session per participant)
|
Threshold detection, discrimination between odorants and odor identification, measured with standardized olfactory tests
|
During the 2-hour testing session (one session per participant)
|
Perception
Time Frame: During the 2-hour testing session (one session per participant)
|
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)
|
Response times
Time Frame: During the 2-hour testing session (one session per participant)
|
Response time to the olfactory/visual stimulus in millisecond
|
During the 2-hour testing session (one session per participant)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Frédéric FAURE, MD, Infirmerie Protestante
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 15, 2016
Primary Completion (Anticipated)
March 15, 2022
Study Completion (Anticipated)
April 15, 2022
Study Registration Dates
First Submitted
February 8, 2017
First Submitted That Met QC Criteria
February 15, 2017
First Posted (Actual)
February 20, 2017
Study Record Updates
Last Update Posted (Actual)
July 21, 2021
Last Update Submitted That Met QC Criteria
July 20, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- 69HCL16_0685
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.
Clinical Trials on Healthy
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
University of PennsylvaniaActive, not recruitingHealthy | Healthy AgingUnited States
-
Chalmers University of TechnologyGöteborg UniversityCompletedHealthy | Nutrition, HealthySweden
-
Hasselt UniversityRecruitingHealthy | Healthy AgingBelgium
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
University of ManitobaNot yet recruitingHealthy | Healthy Diet
-
King's College LondonUniversity of ReadingCompletedHealthy | Healthy AgingUnited Kingdom
Clinical Trials on Odor presentation (for participants' perception)
-
Hospices Civils de LyonRecruiting
-
University of LouisvilleNational Eye Institute (NEI)Recruiting
-
Hospices Civils de LyonRecruiting
-
University of Colorado, DenverNational Institute of Nursing Research (NINR)CompletedHeart Failure | Cancer | COPDUnited States
-
VU University of AmsterdamCompletedPanic Disorder | AgoraphobiaNetherlands
-
Duke UniversityCompletedStress ReductionUnited States
-
Coloplast A/SCompletedNeurogenic Bladder Dysfunction NosDenmark, France, Germany, Norway, Sweden
-
Indiana UniversityRecruitingNASH - Nonalcoholic Steatohepatitis | Cirrhosis, LiverUnited States
-
University Hospitals Bristol and Weston NHS Foundation...CompletedPost Traumatic Stress DisorderUnited Kingdom
-
CardiacSense Ltd.Completed