UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060609 |
|---|---|
| Receipt number | R000069326 |
| Scientific Title | Exploratory Study of Sweat Analysis for Evaluating Stress and Fatigue Associated with Driving Work |
| Date of disclosure of the study information | 2026/02/10 |
| Last modified on | 2026/02/06 19:25:57 |
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Basic information
Public title
Exploratory Study of Sweat Analysis for Evaluating Stress and Fatigue Associated with Driving Work
Acronym
A Study on Stress and Tiredness in Driving Work and Sweat Components
Scientific Title
Exploratory Study of Sweat Analysis for Evaluating Stress and Fatigue Associated with Driving Work
Scientific Title:Acronym
Study on Sweat Analysis for Driving Stress and Fatigue
Region
| Japan |
Condition
Condition
Healthy adults (workers engaged in driving work)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore the association between changes in sweat components and subjective stress/fatigue in healthy adults engaged in driving work by analyzing inorganic and organic components in sweat samples collected before and after work and after music listening. In addition, to obtain reference information for interpreting changes in sweat components by collecting stress-related indicators such as a psychological questionnaire (TDMS-ST) and salivary amylase measurements.
Basic objectives2
Others
Basic objectives -Others
Exploratory investigation of associations between sweat components and subjective stress/fatigue (including feasibility of non-invasive and simple visualization of biological information).
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
To assess the association (correlation/relationship) between sweat components (inorganic and organic components) obtained from sweat samples collected at three time points (before work, after work, and after music listening; three assessments per day for three days) and subjective stress/fatigue indicators (TDMS-ST) and salivary amylase activity measured at the same time points.
Key secondary outcomes
(1) Changes in TDMS-ST and salivary amylase activity before and after music listening (after work vs. after music listening).
(2) Changes in sweat components (inorganic and organic components) over the same period.
(3) Associations between driving work data (e.g., driving time and travel distance) and the above.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Single-arm intervention. After the post-work assessment, participants listen to one track of relaxation/healing music for approximately 5-8 minutes in a seated position in a quiet room, followed by an immediate post-listening assessment. This procedure is repeated for 3days for each participant. Recording: one self-selected track from a 10-track album, Mental Health Music for Working People by Toshiki Kato.
Interventions/Control_2
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
| 30 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Aged 30 to 69 years
Drives a vehicle routinely and can provide driving time and travel distance information
Is aware of feeling stress in daily life and recognizes the need for improvement
Agrees to participate in the music-listening task (no strong aversion to music)
No history of psychiatric disorders or serious diseases
Not pregnant or breastfeeding, and not planning pregnancy
Does not perceive having a condition with very low sweating (e.g., extremely dry skin)
Key exclusion criteria
Currently participating in another clinical trial or participated within the past 4 weeks.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Ito |
Organization
TANAKA PRECIOUS METAL GROUP Co., Ltd.
Division name
TANAKA MIRAI Lab.
Zip code
103-0025
Address
2-6-6, Nihonbashi Kayabacho, Chuo-ku, Tokyo, Japan
TEL
03-6311-5511
itom@ml.tanaka.co.jp
Public contact
Name of contact person
| 1st name | Kunihito |
| Middle name | |
| Last name | Ikeda |
Organization
Della Inc.
Division name
None
Zip code
154-0024
Address
YK Building 9F, 2-2-16 Sangenjaya, Setagaya-ku, Tokyo, Japan
TEL
03-4545-2161
Homepage URL
ikeda@della.co.jp
Sponsor or person
Institute
TANAKA PRECIOUS METAL GROUP Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
TANAKA PRECIOUS METAL GROUP Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Public Health Research Foundation (PHRF), Institutional Review Board / Research Ethics Committee
Address
1-1-7 Nishiwaseda, Shinjuku City, Tokyo, Japan
Tel
03-5287-5070
rinri@phrf.jp
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
| 2026 | Year | 02 | Month | 10 | 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
| 2026 | Year | 02 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 02 | Month | 16 | Day |
Last follow-up date
| 2027 | Year | 07 | 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
| 2026 | Year | 02 | Month | 06 | Day |
Last modified on
| 2026 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069326
