UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063291 |
|---|---|
| Receipt number | R000072446 |
| Scientific Title | The effects of head-mounted bright light therapy device on circadian rhythm and executive function |
| Date of disclosure of the study information | 2026/10/19 |
| Last modified on | 2026/10/15 12:55:26 |
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Basic information
Public title
A study on the effects of bright light on biological clock and cognitive
function
Acronym
The effects of bright light on biological clock and cognitive
function
Scientific Title
The effects of head-mounted bright light therapy device on circadian rhythm and executive function
Scientific Title:Acronym
The effects of bright light therapy device on circadian rhythm and executive function
Region
| Japan |
Condition
Condition
N/A
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of the present study is to investigate the effects of bright light on circadian rhythm and executive function in undergraduate and graduate students using core body temperature and cognitive tasks.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Core Body Temperature
Cognitive Task Scores
Key secondary outcomes
Sleep Metrics
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
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Behavior,custom |
Interventions/Control_1
Light irradiation using a bright light irradiation device(30min)
Interventions/Control_2
Core body temperature measurement (during sleep, approximately 7 hours)
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
| 18 | years-old | <= |
Age-upper limit
| 25 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Healthy men and women aged 18 to 25 years at the time of obtaining consent
2. Those who have received sufficient explanation about participation in the study, fully understand it, and have provided written consent of their own free will
Key exclusion criteria
1) Individuals currently undergoing regular medical visits or taking medication for conditions such as mental disorders or sleep disorders
2) Individuals currently receiving treatment for physical illnesses or injuries
3) Individuals with a history of eye disease
4) Individuals with a history of gastrointestinal disease or abdominal surgery
5) Individuals with swallowing disorders
6) Individuals scheduled to undergo procedures involving electromagnetic waves (such as MRI) on the day of the experiment or the following day
7) Individuals who have previously experienced problems when taking capsules
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Nishida |
Organization
Waseda University
Division name
Faculty of Sport Sciences
Zip code
359-1192
Address
2-579-15 Mikajima, Tokorozawa, Saitama 359-1192 JAPAN
TEL
0429476771
nishida@waseda.jp
Public contact
Name of contact person
| 1st name | Masaki |
| Middle name | |
| Last name | Nishida |
Organization
Waseda University
Division name
Faculty of Sport Sciences
Zip code
359-1192
Address
2-579-15 Mikajima, Tokorozawa, Saitama 359-1192 JAPAN
TEL
0429476771
Homepage URL
nishida@waseda.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
Funding Source
Organization
Waseda University
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
Waseda University Ethics Review Committee for Research Involving Human Subjects
Address
513 Waseda-Tsurumakicho, Shinjuku, Tokyo 162-0041 JAPAN
Tel
0429476771
nishida@waseda.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 | 10 | Month | 19 | 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 | 07 | Month | 01 | Day |
Date of IRB
| 2026 | Year | 10 | Month | 09 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 25 | 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
| 2026 | Year | 10 | Month | 15 | Day |
Last modified on
| 2026 | Year | 10 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072446
