BehaviorNCT03726840
Sensory Stimulation During Simulated Driving
A study testing Fragrance in people with Behavior, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
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 Read more about this study
- Who is it for?
- Ages 24 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Behavior
- What is being tested?
- Fragrance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Oct 2018to 30 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- valid drivers license
- normal or corrected to normal vision
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinanti Childrens Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: 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
Read the 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.
- Conditions
- Behavior
- Being tested
- Fragrance
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FragranceOther
peppermint, rosemary, and zest/pulp will increase memory recall for navigation and improve reaction times for braking, compared to performance during unscented conditions
| Study group | Role | What they receive |
|---|---|---|
| Driving performance no fragrance | No intervention | healthy young (ages 24-35 years) and older (ages 60-85 years) with no fragrance |
| Driving performance Fragrance | Experimental | healthy young (ages 24-35 years) and older (ages 60-85 years) with fragrance Receives: Other: Fragrance |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 minutes
Secondary outcomes (3)
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
Measured: 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
Measured: 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
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2018
- Study start8 Oct 2018
- Primary completion31 Dec 2018
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03726840
- Sponsor's protocol ID
- 2018-2204
- Status last verified
- Jul 2020
- First submitted
- 30 Oct 2018
- Last updated
- 14 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensory-based Stimulation to Increase Alertness and Behavioral Performance During Simulated Driving
- ClinicalTrials.gov ID
- NCT03726840
- Acronym / sponsor ID
- 2018-2204
- Conditions
- Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- 8 Oct 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 1 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Driving performance no fragrance | No intervention | –healthy young (ages 24-35 years) and older (ages 60-85 years) with no fragrance |
| Driving performance Fragrance | Experimental | Other: Fragrancehealthy young (ages 24-35 years) and older (ages 60-85 years) with fragrance |
Who may qualify
- Ages
- 24 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- valid drivers license
- normal or corrected to normal vision
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fragrancepeppermint, rosemary, and zest/pulp will increase memory recall for navigation and improve reaction times for braking, compared to performance during unscented conditions | Other | Driving performance Fragrance |
Primary outcome
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.
3 secondary outcomes
Braking Assessment
Time frame: 15 minutes
Workload and mood assessment
Time frame: 5 minutes
Scent assessment
Time frame: 5 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fragrance in people with Behavior, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Navigation Assessment (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2020.