UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Development of a bright light therapy apparatus
Title of the study (Brief title)	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	Jun Miura
Organization	Hokkaido Pharmaceutical University
Division name	Pharmacotherapy
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	Jun Miura
Organization	Hokkaido Pharmaceutical University
Division name	Pharmacotherapy
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 12 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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