Sensory Stimulation During Simulated Driving

Behavior Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03726840
• Other study ID #: 2018-2204
• Status: Completed
• Phase: N/A
• Start date: October 8, 2018
• Est. completion date: June 30, 2019

Study information

• Verified date: July 2020
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: June 30, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 24 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Behavior

Intervention

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

Locations

Country	Name	City	State
United States	Cincinanti Childrens Hospital Medical Center	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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