UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056003 |
|---|---|
| Receipt number | R000064000 |
| Scientific Title | A study on the effect of chewing gum having strong refreshing feeling during simulated driving on reducing drowsiness: A randomized controlled cross-over study |
| Date of disclosure of the study information | 2024/11/07 |
| Last modified on | 2024/10/31 14:14:29 |
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Basic information
Public title
A study on the effect of chewing gum having strong refreshing feeling during simulated driving on reducing drowsiness: A randomized controlled cross-over study
Acronym
A study on the effect of chewing gum having strong refreshing feeling during simulated driving on reducing drowsiness: A randomized controlled cross-over study
Scientific Title
A study on the effect of chewing gum having strong refreshing feeling during simulated driving on reducing drowsiness: A randomized controlled cross-over study
Scientific Title:Acronym
A study on the effect of chewing gum having strong refreshing feeling during simulated driving on reducing drowsiness: A randomized controlled cross-over study
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of having the target food on drowsiness reduction during simulated driving
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Subjective assessment of drowsiness using Japanese version of Karolinska Sleepiness Scale (KSS-J) before and after simulated driving
Key secondary outcomes
Accuracy and reaction time variability of digit vigilance task (DVT)
Neurophysiological measures during DVT (total-Hb of dorsolateral prefrontal cortex and medial prefrontal cortex, heart rate variability indices, facial expression drowsiness score variability)
subjective VAS score variability in response to "how heavy are your eyelids?"
Sleep time of the previous day
Subject information (sex, age)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
Participants take two pieces of the target food for each intervention. After a washout period, participants take nothing for each intervention.
Interventions/Control_2
Participants take nothing for each intervention. After a washout period, participants take two pieces of the target food for each intervention.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
･Male and female adults (20 - 60 years old)
･Right-handed
･Possessing a valid driving license for ordinary motor vehicles and driving for more than two hours at least once every three years
･No health problems for now (No history of serious illness / mental disorder)
･Having sleep for six hours or less during week days
･Not allergic to food (gelatine)
･Not pregnant or not breastfeeding
･Having normal or corrected-to-normal vision for both eyes (greater than or equal to 0.7)
Key exclusion criteria
･When the investigator in charge judges that there is a problem affecting mastication such as participants who wear braces that are not removable.
･Taking any medication that can affect sleep or sleepiness
･Night-shift workers (mostly active outside the daytime)
･Having visited foreign countries where there is two hours or longer time difference within two weeks before the start of this experiment, or planning to visit foreign countries where there is two hours or longer time difference during this experiment
･When the investigator in charge judges that participating in this experiment is not appropriate.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Masanori |
| Middle name | |
| Last name | Shoji |
Organization
NeU Corporation
Division name
-
Zip code
1010048
Address
2-2 Niikura Building, Kandatsukasamachi, Chiyoda-ku, Tokyo
TEL
0362509050
masanori.shoji@neu-brains.com
Public contact
Name of contact person
| 1st name | Shinji |
| Middle name | |
| Last name | Yoshida |
Organization
NeU Corporation
Division name
Neuromarketing Business Unit
Zip code
1010048
Address
2-2 Niikura Building, Kandatsukasamachi, Chiyoda-ku, Tokyo
TEL
0362509050
Homepage URL
shinji.yoshida@neu-brains.com
Sponsor or person
Institute
NeU Corporation
Institute
Department
Personal name
Shinji Yoshida
Funding Source
Organization
Lotte Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Lotte Co., Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shiba Palace Clinic Ethics Review Committee
Address
DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan
Tel
0354081599
-
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 11 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2024 | Year | 10 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 11 | Month | 15 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 10 | Month | 31 | Day |
Last modified on
| 2024 | Year | 10 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064000
