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Sensory Stimulation During Simulated Driving

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ClinicalTrials.gov Identifier: NCT03726840
Recruitment Status : Recruiting
First Posted : November 1, 2018
Last Update Posted : November 1, 2018
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

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

Condition or disease Intervention/treatment Phase
Behavior Other: Fragrance Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Sensory-based Stimulation to Increase Alertness and Behavioral Performance During Simulated Driving
Actual Study Start Date : October 8, 2018
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : June 30, 2019

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




Primary Outcome Measures :
  1. Navigation Assessment [ Time Frame: 30 minutes ]
    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.


Secondary Outcome Measures :
  1. Braking Assessment [ Time Frame: 15 minutes ]
    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

  2. Workload and mood assessment [ Time Frame: 5 minutes ]
    participants will be asked to rank their perceived mental, physical, and temporal demands in combination with their performance, effort and frustration

  3. Scent assessment [ Time Frame: 5 minutes ]
    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



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Ages Eligible for Study:   24 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03726840


Contacts
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Contact: Brooke Gadd 513-803-7321 brooke.gadd@cchmc.org
Contact: Kim Barber Foss 513-636-5971 kim.foss@cchmc.org

Locations
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United States, Ohio
Cincinanti Childrens Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Kim D Barber Foss, MS    513-636-5971    kim.foss@cchmc.org   
Principal Investigator: Adam D Kiefer, PhD         
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati

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Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT03726840     History of Changes
Other Study ID Numbers: 2018-2204
First Posted: November 1, 2018    Key Record Dates
Last Update Posted: November 1, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No