UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056188 |
|---|---|
| Receipt number | R000064196 |
| Scientific Title | Effects of sleep deprivation on the cognitive function |
| Date of disclosure of the study information | 2025/12/31 |
| Last modified on | 2025/02/25 13:45:23 |
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Basic information
Public title
Effects of sleep deprivation on the cognitive function
Acronym
Effects of sleep deprivation on the cognitive function
Scientific Title
Effects of sleep deprivation on the cognitive function
Scientific Title:Acronym
Effects of sleep deprivation on the cognitive function
Region
| Japan |
Condition
Condition
None (Healthy Adults)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To understand the effect of sleep deprivation on the cognitive function
Basic objectives2
Others
Basic objectives -Others
To understand the effect of sleep deprivation on the cognitive performance
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Subjective psychological test
Key secondary outcomes
Subjective sleepiness
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
1 normal sleep
2 sleep deprivation
The order of laboratory is (1,2).
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
| 20 | years-old | <= |
Age-upper limit
| 40 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Healthy males and females aged 20 to 40
2. Those whose Pittsburgh Sleep Quality Index score of less than 6
3. Native Japanese speakers
Key exclusion criteria
1. Individuals with serious illnesses under treatment or a history of mental illness.
2. Individuals judged to have sleep problems by the principal investigator or researchers (doctors) at Shiga University of Medical Science.
3. Individuals taking medication or supplements related to sleep.
4. Individuals unable to stay for 3 days and 2 nights.
5. Individuals planning to drive (including bicycles and scooters) or engage in other hazardous activities on the day of the test.
6. Individuals consuming excessive alcohol (more than 20g of pure alcohol per day on average).
7. Individuals with a smoking habit (those who have smoked daily or occasionally in the past three months).
8. Individuals unable to get at least 6 hours of sleep per day from one week before the test until the test day, due to night shifts, etc.
9. Individuals with sleep disorders (those whose Pittsburgh Sleep Quality Index score of 6 or higher).
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | shima |
| Middle name | |
| Last name | okada |
Organization
Ritsumeikan University
Division name
Faculty of Science and Engineering
Zip code
5691022
Address
1-1-1, Nojihigashi,Kusatsu,Shiga,Japan
TEL
0775614939
s-okada@fc.ritsumei.ac.jp
Public contact
Name of contact person
| 1st name | shima |
| Middle name | |
| Last name | okada |
Organization
Ritsumeikan University
Division name
Faculty of Science and Engineering
Zip code
5691022
Address
1-1-1, Nojihigashi,Kusatsu,Shiga,Japan
TEL
0775614939
Homepage URL
s-okada@fc.ritsumei.ac.jp
Sponsor or person
Institute
Ritsumeikan University
Institute
Department
Personal name
Funding Source
Organization
Kirin Holdings Company, Limited
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Shiga University of Medical Science
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ritsumeikan University Ethics Review Committee for Medical Research Involving Human Subjects
Address
1-1-1, Nojihigashi,Kusatsu,Shiga,Japan
Tel
077-599-4175
b-rinri@st.ritsumei.ac.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
立命館大学びわこくさつキャンパスエポック21（滋賀県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 12 | Month | 31 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 11 | Month | 06 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 06 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 15 | Day |
Last follow-up date
| 2025 | Year | 12 | 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 | 11 | Month | 19 | Day |
Last modified on
| 2025 | Year | 02 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064196
