Sensory Stimulation During Simulated Driving

Sensory-based Stimulation to Increase Alertness and Behavioral Performance During Simulated Driving

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

Study Overview

• Status: Completed
• Conditions: Behavior
• Intervention / Treatment: Other: Fragrance

Detailed Description

This study will examine the effect of scented odors on the attention and behavioral performance of healthy young adult and older adult drivers. Past research indicates that specific scented odors (i.e., peppermint and cinnamon) enhance motivation, performance and alertness, decrease fatigue and stimulate the central nervous system in a variety of contexts. The current study will examine the effect of three different odors on simulated driving as participants perform navigation and braking scenarios. This study will be the first of its kind to elucidate the association between specific scents and performance gains in simulated driving. The data will serve as proof-of-concept for eventual patient focused interventions relative to sensory stimulation and driving.

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinanti Childrens Hospital Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 83 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• valid drivers license
• normal or corrected to normal vision

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Driving performance no fragrance; healthy young (ages 24-35 years) and older (ages 60-85 years) with no fragrance
Experimental: Driving performance Fragrance; healthy young (ages 24-35 years) and older (ages 60-85 years) with fragrance	Other: Fragrance; peppermint, rosemary, and zest/pulp will increase memory recall for navigation and improve reaction times for braking, compared to performance during unscented conditions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Braking Assessment	a virtual stop sign will appear suddenly in the middle of the visual field. The participant will be instructed to come to a stop as quickly as possible and to remain stopped until the stop sign disappears	15 minutes
Workload and mood assessment	participants will be asked to rank their perceived mental, physical, and temporal demands in combination with their performance, effort and frustration	5 minutes
Scent assessment	A short fragrance questionnaire will be given after each study session, in order to ensure that participants are able to distinguish between non-scented and scented conditions	5 minutes

Collaborators and Investigators

• Sponsor: Children's Hospital Medical Center, Cincinnati

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2018
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): June 30, 2019

Study Registration Dates

• First Submitted: October 30, 2018
• First Submitted That Met QC Criteria: October 30, 2018
• First Posted (Actual): November 1, 2018

Study Record Updates

• Last Update Posted (Actual): July 14, 2020
• Last Update Submitted That Met QC Criteria: July 13, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 2018-2204

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No