UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054581 |
|---|---|
| Receipt number | R000061841 |
| Scientific Title | Biogas-based fatigue prediction during driving |
| Date of disclosure of the study information | 2024/06/05 |
| Last modified on | 2024/12/17 13:40:30 |
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Basic information
Public title
Research on fatigue prediction during driving
Acronym
FPD
Scientific Title
Biogas-based fatigue prediction during driving
Scientific Title:Acronym
BFPD
Region
| Japan |
Condition
Condition
N.A.
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Using biogases dispersed in the room, we investigate the prediction method for fatigue during driving and the cognitive and physical load that may cause fatigue.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Feeling of fatigue
Key secondary outcomes
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Diagnosis
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
A low traffic load and long driving hours condition
Interventions/Control_2
A low traffic load and cognitive task condition
Interventions/Control_3
A high traffic load condition
Interventions/Control_4
An automated driving monitoring condition
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(i) Persons who are able to obtain written consent for research participation based on their voluntary agreement.
(ii) Persons who are at least 18 years old and less than 80 years old at the time of obtaining consent.
(iii) Gender: male or female
(iv) Persons who hold a regular driver's license and have been driving a regular car (or a commercial vehicle) at least once a week for the past six months.
(v) Persons who can answer the questionnaire in Japanese.
Key exclusion criteria
(i) Women who are pregnant or have the possibility of pregnancy
(ii) Persons who are of a physique that would interfere with the operation of the driving simulator (height: less than 150cm and more than 185cm, weight: 100kg as a standard).
(iii) Persons who suffer from severe car sickness, or those who have experienced sickness or physical discomfort while using the driving simulator or watching the images in the past.
(iv) Persons who experience redness or skin rash by applying adhesive plasters, etc.
(v) Persons with a history of metabolism-related diseases such as diabetes, hypertension, dyslipidemia, thyroid dysfunction, etc.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Takafumi |
| Middle name | Justin |
| Last name | Ando |
Organization
National Institute of Advanced Industrial Science and Technology
Division name
Information Technology and Human Factors
Zip code
305-8566
Address
Higashi 1-1-1, Tsukuba, Ibaraki
TEL
050-3522-3226
takafumi.ando@aist.go.jp
Public contact
Name of contact person
| 1st name | Takafumi |
| Middle name | |
| Last name | Ando |
Organization
National Institute of Advanced Industrial Science and Technology
Division name
Information Technology and Human Factors
Zip code
305-8566
Address
Higashi 1-1-1, Tsukuba, Ibaraki
TEL
050-3522-3226
Homepage URL
takafumi.ando@aist.go.jp
Sponsor or person
Institute
National Institute of Advanced Industrial Science and Technology
Institute
Department
Personal name
Funding Source
Organization
National Institute of Advanced Industrial Science and Technology
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Institute of Advanced Industrial Science and Technology Committee on Bioethics
Address
Higashi 1-1-1, Tsukuba, Ibaraki
Tel
029-861-2120
safe-life-ml@aist.go.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
| 2024 | Year | 06 | Month | 05 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 05 | Month | 02 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 25 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2028 | 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 | 06 | Month | 05 | Day |
Last modified on
| 2024 | Year | 12 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061841
