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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025694
Receipt No. 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

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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
Email 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
Email miura-j@hokuyakudai.ac.jp

Sponsor
Institute Muroran Institute of Technology, College of Design and Manufacturing Technology
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029558

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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