Sensory Stimulation During Simulated Driving
Sensory-based Stimulation to Increase Alertness and Behavioral Performance During Simulated Driving
1 other identifier
interventional
75
1 country
1
Brief Summary
The purpose of this study is to examine the effect of three specific odors on simulated driving performance. It is hypothesized that the presence of peppermint, rosemary, and zest/pulp will increase memory recall for navigation and improve reaction times for braking, compared to performance during unscented conditions
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 8, 2018
CompletedFirst Submitted
Initial submission to the registry
October 30, 2018
CompletedFirst Posted
Study publicly available on registry
November 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2019
CompletedJuly 14, 2020
July 1, 2020
3 months
October 30, 2018
July 13, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Navigation Assessment
The navigation task will consist of up to six blocks of instruction/recall segments that will contain the same number of turns over the same distance, but with novel environmental stimuli and a randomized order of turns unique to each block.
30 minutes
Secondary Outcomes (3)
Braking Assessment
15 minutes
Workload and mood assessment
5 minutes
Scent assessment
5 minutes
Study Arms (2)
Driving performance no fragrance
NO INTERVENTIONhealthy young (ages 24-35 years) and older (ages 60-85 years) with no fragrance
Driving performance Fragrance
EXPERIMENTALhealthy young (ages 24-35 years) and older (ages 60-85 years) with fragrance
Interventions
peppermint, rosemary, and zest/pulp will increase memory recall for navigation and improve reaction times for braking, compared to performance during unscented conditions
Eligibility Criteria
You may qualify if:
- valid drivers license
- normal or corrected to normal vision
You may not qualify if:
- no drivers license
- hyperopic vision without contact lenses
- history of congenital or acquired cognitive, ophthalmologic, or neurological disorders including developmental delay, brain tumor, stroke, or known peripheral or central vestibular disorders
- participants who have been diagnosed with Attention Deficit Hyperactivity Disorder (ADHD) will be excluded
- Participants will also be excluded if they have: (a) a history of skin irritation or sensitivity to scented products or cosmetics, (b) known skin allergies, sensitive skin or allergies to fragrance, (c) suffers from a cold, allergy, sinus condition or any other condition that might interfere with their sense of smell and (d) is pregnant or nursing.
- Participants will also be excluded if they smoke or use tobacco related products
- participants will be excluded if they commonly experience motion sickness
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cincinanti Childrens Hospital Medical Center
Cincinnati, Ohio, 45229, United States
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 30, 2018
First Posted
November 1, 2018
Study Start
October 8, 2018
Primary Completion
December 31, 2018
Study Completion
June 30, 2019
Last Updated
July 14, 2020
Record last verified: 2020-07