UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056530 |
|---|---|
| Receipt number | R000064600 |
| Scientific Title | An exploratory study on the effects of fatigue on sleep and cognitive function |
| Date of disclosure of the study information | 2024/12/23 |
| Last modified on | 2025/09/25 16:40:55 |
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Basic information
Public title
An exploratory study on the effects of fatigue on sleep and cognitive function (SWE-2024-04)
Acronym
An exploratory study on the effects of fatigue on sleep and cognitive function
Scientific Title
An exploratory study on the effects of fatigue on sleep and cognitive function
Scientific Title:Acronym
An exploratory study on the effects of fatigue on sleep and cognitive function
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of fatigue on sleep and cognitive function.
Basic objectives2
Others
Basic objectives -Others
To evaluate the effects of fatigue on sleep and cognitive function.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cognitive function (attention)
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
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
6
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Administration of low-intensity cognitive tasks for 2 days, washout for 5 days, administration of middle-intensity cognitive tasks for 2 days, washout for 5 days, administration of high-intensity cognitive tasks for 2 days
Interventions/Control_2
Administration of low-intensity cognitive tasks for 2 days, washout for 5 days, administration of high-intensity cognitive tasks for 2 days, washout for 5 days, administration of middle-intensity cognitive tasks for 2 days
Interventions/Control_3
Administration of middle-intensity cognitive tasks for 2 days, washout for 5 days, administration of low-intensity cognitive tasks for 2 days, washout for 5 days, administration of high-intensity cognitive tasks for 2 days
Interventions/Control_4
Administration of middle-intensity cognitive tasks for 2 days, washout for 5 days, administration of high-intensity cognitive tasks for 2 days, washout for 5 days, administration of low-intensity cognitive tasks for 2 days
Interventions/Control_5
Administration of high-intensity cognitive tasks for 2 days, washout for 5 days, administration of low-intensity cognitive tasks for 2 days, washout for 5 days, administration of middle-intensity cognitive tasks for 2 days
Interventions/Control_6
Administration of high-intensity cognitive tasks for 2 days, washout for 5 days, administration of middle-intensity cognitive tasks for 2 days, washout for 5 days, administration of low-intensity cognitive tasks for 2 days
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 30 | years-old | <= |
Age-upper limit
| 49 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Males and females aged 30 to 49 years
(2) Individuals who can visit the designated study site on scheduled examination dates
(3) Individuals who have fully understood the purpose and content of the study and have provided written informed consent
Key exclusion criteria
(1) Individuals with a history of neurological or psychiatric disorders, or those suspected of having such disorders
(2) Individuals with injuries or medical conditions that interfere with the operation of electronic devices such as computers
(3) Heavy alcohol drinkers
(4) Shift workers, night shift workers, those who are routinely awakened during the night, or those with irregular lifestyles
(5) Any other individuals deemed unsuitable for the study by the Principal Investigator
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yoshihisa |
| Middle name | |
| Last name | Kaneda |
Organization
Suntory Wellness Limited
Division name
Institute for Science of Life
Zip code
6190284
Address
8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan.
TEL
050-1804-0218
Yoshihisa_Kaneda@suntory.co.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Morita |
Organization
Suntory Wellness Limited
Division name
Institute for Science of Life
Zip code
6190284
Address
8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan.
TEL
050-1804-0185
Homepage URL
Sa_Morita@suntory.co.jp
Sponsor or person
Institute
Suntory Wellness Limited
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB of Fukuda Clinic
Address
2F Shin-Osaka Brick Building, 1-6-1, Miyahara, Yodogawa-ku, Osaka-shi, Osaka Japan
Tel
06-6398-0203
fukudaclinicIRB@gmail.com
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 | 12 | Month | 23 | 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
Completed
Date of protocol fixation
| 2024 | Year | 12 | Month | 21 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 21 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 23 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 27 | 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 | 12 | Month | 21 | Day |
Last modified on
| 2025 | Year | 09 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064600
