UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000055037 |
|---|---|
| Receipt number | R000062853 |
| Scientific Title | The impact of daytime bright light on nocturnal sleep quality |
| Date of disclosure of the study information | 2024/07/21 |
| Last modified on | 2024/07/21 23:32:32 |
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Basic information
Public title
The impact of daytime bright light on nocturnal sleep quality
Acronym
The impact of daytime bright light on nocturnal sleep quality
Scientific Title
The impact of daytime bright light on nocturnal sleep quality
Scientific Title:Acronym
The impact of daytime bright light on nocturnal sleep quality
Region
| Japan |
Condition
Condition
Healthy person
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the impact of daytime bright light on nocturnal sleep quality through subjective and objective evaluations of sleep
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Subjective evaluations of sleep
･OSA-MA (drowsiness upon awakening, initiation and maintenance of sleep, frequent dreaming, refreshing, sleep length)
Objective evaluations of sleep
･actigraph (activity, bedtime, sleeping time, wake-up time, sleep duration etc)
･electroencephalogram (sleep onset latency, nocturnal awakening, total sleep time, sleep efficiency, REM/non-REM sleep)
･autonomic nervous activity (heart rate, HF, LF/HF)
･core body temperature
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Normal light(5 days)-Washout period(2 days)-Bright light(5 days)
Spend 1.5 hours each day in the laboratory under each condition's light environment
Interventions/Control_2
Bright light(5 days)-Washout period(2 days)-(Normal light(5 days)
Spend 1.5 hours each day in the laboratory under each condition's light environment
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
Healthy 20-40 year old men and women
Key exclusion criteria
Has a disease under treatment, sleep disorder, eye disease, photosensitivity, or menstrual disorder
Working early mornings or late nights during shift work, etc
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Naoko |
| Middle name | |
| Last name | Kubota |
Organization
Hokkaido University of Science
Division name
Faculty of Health Sciences, Dept. of Nurshing
Zip code
006-8585
Address
7-15-4-1 Maeda,Teine,Sapporo,hokkaido,japan
TEL
0116882367
kubota-n@hus.ac.jp
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | Kubota |
Organization
Hokkaido University of Science
Division name
Faculty of Health Sciences, Dept. of Nurshing
Zip code
006-8585
Address
7-15-4-1 Maeda,Teine,Sapporo,hokkaido,japan
TEL
0116882367
Homepage URL
kubota-n@hus.ac.jp
Sponsor or person
Institute
Hokkaido University of Science
Institute
Department
Personal name
Funding Source
Organization
Hokkaido University of Science
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
Hokkaido University of Science Ethics Committee
Address
7-15-4-1 Maeda, Teine, Sapporo, Hokkaido, JAPAN
Tel
0116882241
kubota-n@hus,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
| 2024 | Year | 07 | Month | 21 | 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
| 2024 | Year | 07 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2025 | 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 | 07 | Month | 21 | Day |
Last modified on
| 2024 | Year | 07 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000062853
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
