UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025694 |
|---|---|
| Receipt number | R000029558 |
| Scientific Title | Development of a bright light therapy apparatus |
| Date of disclosure of the study information | 2017/01/24 |
| Last modified on | 2018/04/06 12:19:26 |
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Basic information
Public title
Development of a bright light therapy apparatus
Acronym
Development of a bright light therapy apparatus
Scientific Title
Development of a bright light therapy apparatus
Scientific Title:Acronym
Development of a bright light therapy apparatus
Region
| Japan |
Condition
Condition
Sleepiness
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate safety and effects of bright light therapy with reduced blue light on sleepiness
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
calculation task score immediately after light therapy
Key secondary outcomes
subjective sleepiness on rising
subjective sleep quality
sublingual temperature
sleep quality
total sleep time
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
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
No light, or 10000-lux light of which the blue light content was reduced by 50% or 30%, is administered from 0500 to 0530 for four consecutive days each, with four-day intermission.
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
| 25 | years-old | >= |
Gender
Male
Key inclusion criteria
healthy men
Key exclusion criteria
subjects who are treated for any illnesses
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Jun Miura |
Organization
Hokkaido Pharmaceutical University
Division name
Pharmacotherapy
Zip code
Address
7-15-4-1 Maeda, Teine, Sapporo, Hokkaido, Japan
TEL
011-676-8700
miura-j@hokuyakudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Jun Miura |
Organization
Hokkaido Pharmaceutical University
Division name
Pharmacotherapy
Zip code
Address
7-15-4-1 Maeda, Teine, Sapporo, Hokkaido, Japan
TEL
011-676-8700
Homepage URL
miura-j@hokuyakudai.ac.jp
Sponsor or person
Institute
Muroran Institute of Technology, College of Design and Manufacturing Technology
Institute
Department
Personal name
Funding Source
Organization
Muroran Institute of Technology, College of Design and Manufacturing Technology
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
Address
Tel
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
室蘭工業大学もの創造系領域
室蘭工業大学保健管理センター
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 01 | Month | 24 | 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
| 2016 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 01 | Month | 24 | Day |
Last follow-up date
| 2017 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
| 2017 | Year | 08 | Month | 15 | Day |
Date analysis concluded
| 2017 | Year | 09 | Month | 25 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 01 | Month | 16 | Day |
Last modified on
| 2018 | Year | 04 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029558
| 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 |
