UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of daytime napping under two different light conditions after simulated night work on biological rhythm in healthy human
Title of the study (Brief title)	The effect of daytime napping under two different light conditions after simulated night work on biological rhythm in healthy human
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To confirm that daytime napping under bright light condition after night work is more effective to keep the phase of biological rhythm in human compared than the napping under dim light condition.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Delta of Dim Light Melatonin Onset between baseline and next day
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	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	[Bright light condition] Taking a daytime nap under bright light condition after a simulated night work [Dim Light condition] Taking a daytime nap under dim light condition after a simulated night work These conditions will be performed more than one week apart from each other.
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	20 years-old <=
Age-upper limit	40 years-old >
Gender	Male
Key inclusion criteria	Healthy adult male
Key exclusion criteria	1) Mental diseases 2) Extreame morningness-type 3) Extreame eveningness-type 4) Sleep disorder 5) Smorker
Target sample size	15

Research contact person
Name of lead principal investigator	Tomoko Wakamura
Organization	Graduate School of Medicine, Kyoto University
Division name	Human Health Sciences
Address	53 Shogoin-Kawahara-cho, Sakyo-ku, Kyoto-city, Kyoto
TEL	075-751-3974
Email	wakamura.tomoko.5v@kyoto-u.ac.jp

Public contact
Name of contact person	Tomoko Wakamura
Organization	Graduate School of Medicine, Kyoto University
Division name	Human Health Sciences
Address	53 Shogoin-Kawahara-cho, Sakyo-ku, Kyoto-city, Kyoto
TEL	075-751-3974
Homepage URL
Email	wakamura.tomoko.5v@kyoto-u.ac.jp

Sponsor
Institute	Graduate School of Medicine, Kyoto University
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science (JSPS)
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

Other administrative information
Date of disclosure of the study information	2016 Year 02 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 01 Month 19 Day
Anticipated trial start date	2016 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 01 Month 19 Day
Last modified on	2018 Year 01 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023824