UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052341 |
|---|---|
| Receipt number | R000059755 |
| Scientific Title | Effects of next generation lighting system that selectively stimulates and controls intrinsically photosensitive retinal ganglion cells (ipRGCs) on human circadian rhythms |
| Date of disclosure of the study information | 2023/12/25 |
| Last modified on | 2023/09/28 17:40:42 |
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Basic information
Public title
Effects of next generation lighting system that selectively stimulates and controls intrinsically photosensitive retinal ganglion cells (ipRGCs) on human circadian rhythms
Acronym
Effects of next generation lighting system that selectively stimulates and controls intrinsically photosensitive retinal ganglion cells (ipRGCs) on human circadian rhythms
Scientific Title
Effects of next generation lighting system that selectively stimulates and controls intrinsically photosensitive retinal ganglion cells (ipRGCs) on human circadian rhythms
Scientific Title:Acronym
Effects of next generation lighting system that selectively stimulates and controls intrinsically photosensitive retinal ganglion cells (ipRGCs) on human circadian rhythms
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine how different types of light in a one-hour early morning exposure affect human temperature rhythms.
Basic objectives2
Others
Basic objectives -Others
To determine how different types of light in a one-hour early morning exposure affect human melatonin rhythms.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Phase shift in rectal temperature
Key secondary outcomes
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
| Other |
Interventions/Control_1
Light with different control methods
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
| 18 | years-old | <= |
Age-upper limit
| 39 | years-old | >= |
Gender
Male
Key inclusion criteria
Since the purpose is to collect basic data, the study will be conducted with adults, not the elderly.
Key exclusion criteria
(1) Patients with a result score of 3 or 4 on the Cornell Medical Index for neurosis emotional disorders
(2) Extreme morning person or extreme night person in Mornings Eveningness Questionnaire
(3) Pittsburgh Sleep Questionnaire with a score of 6 or higher
(4) Those who have had a change in their living hours due to shift work or travel to time zones within one month
(5) Those who are taking any oral medication or smoking
(6) Those who has color vision variation
(7) Students who are currently enrolled or may be enrolled in a course that the principal investigator is taking
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Tomoko |
| Middle name | |
| Last name | Wakamura |
Organization
Kyoto University
Division name
Human Health Sciences, Graduate School of Medicine
Zip code
606-8507
Address
53, Shogoin, Kawahara-cho, Sakyo-ku, Kyoto
TEL
81-75-751-3974
wakamura.tomoko.5v@kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomoko |
| Middle name | |
| Last name | Wakamura |
Organization
Kyoto University
Division name
Human Health Sciences, Graduate School of Medicine
Zip code
606-8507
Address
53, Shogoin, Kawahara-cho, Sakyo-ku, Kyoto
TEL
81-75-751-3974
Homepage URL
wakamura.tomoko.5v@kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
ELM Inc.
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
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Konoe-cho, Sakyo-ku, Kyoto
Tel
075-753-4680
ethcom@kuhp.kyoto-u.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 12 | Month | 25 | 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
| 2023 | Year | 12 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 12 | Month | 25 | Day |
Last follow-up date
| 2024 | 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
| 2023 | Year | 09 | Month | 28 | Day |
Last modified on
| 2023 | Year | 09 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059755
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
