A study on the effect of chewing gum having strong refreshing feeling during simulated driving on reducing drowsiness: A randomized controlled cross-over study

A study on the effect of chewing gum having strong refreshing feeling during simulated driving on reducing drowsiness: A randomized controlled cross-over study - A study on the effect of chewing gum having strong refreshing feeling during simulated driving on reducing drowsiness: A randomized controlled cross-over study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000056003

Enrollment

Registered

2024-11-07

Start date

2024-11-15

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy adult

Interventions

Participants take two pieces of the target food for each intervention. After a washout period, participants take nothing for each intervention. Participants take nothing for each intervention. After a

Eligibility

Sex/Gender

All

Inclusion criteria

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)

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Subjective assessment of drowsiness using Japanese version of Karolinska Sleepiness Scale (KSS-J) before and after simulated driving	—

Secondary

Measure	Time frame
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)	—

Measure

Time frame

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)

—

Countries

Japan

Contacts

Public ContactShinji Yoshida

NeU Corporation Neuromarketing Business Unit

shinji.yoshida@neu-brains.com0362509050

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026