UMIN-CTR Clinical Trial

Basic information
Public title	Understanding the health effects and susceptibility factors of circadian misaligngment
Acronym	Understanding the health effects and susceptibility factors of circadian misaligngment
Scientific Title	Understanding the health effects and susceptibility factors of circadian misaligngment
Scientific Title:Acronym	Understanding the health effects and susceptibility factors of circadian misaligngment
Region	Japan

Condition
Condition	Not applicable
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the incidence of internal desynchrony during a stay in the dim light environment and reveal the vulnerable factors (light sensitivity, circadian preferences) and health effects (stress response, mood, alertness, and psychomotor performance).
Basic objectives2	Others
Basic objectives -Others	Differences of circadian rhythm phase (The onset of melatonin secretion and nadir of rectal temperature)
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	The magnitude of Internal desynchrony will be calculated by the discrepancy of the circadian phases between on first experimental day and second experimental day during a stay in the temporal isolation laboratory under dim light environments.
Key secondary outcomes	The level of a stress response, mood, alertness, and psychomotor performance will be calculated by cortisol awakening response and salivary stress hormone, questionnaire, electroencephalography, and test battery on the second and third day, respectively, and compared to those on the first day. The correlation analyses with the magnitude of internal desynchrony will also be performed. Participants will be stratified by eligible vulnerable factors (light sensitivity and circadian preferences), and group differences of the magnitude of internal desynchrony will be evaluated.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Behavior,custom Other
Interventions/Control_1	Staying at dim light environment (<150lux) for 3 days
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	49 years-old >=
Gender	Male
Key inclusion criteria	Male with eligible age (>=20, <=49 years old)
Key exclusion criteria	Affected with sleep, physical, or psychiatric disorders Using drugs which may affect sleep Affected with disease of the rectum Worked night shifts or traveled across time zones in the previous 6 months Difficulty for staying laboratory
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Shingo Middle name Last name Kitamura
Organization	National Center of Neurology and Psychiatry
Division name	National Institute of Mental Health, Department of psychophysiology
Zip code	187-8553
Address	4-1-1, Ogawa-Higashi, Kodaira, Tokyo
TEL	042-341-2712(6266)
Email	s-kita@ncnp.go.jp

Public contact
Name of contact person	1st name Shingo Middle name Last name Kitamura
Organization	National Center of Neurology and Psychiatry
Division name	National Institute of Mental Health, Department of psychophysiology
Zip code	187-8553
Address	4-1-1, Ogawa-Higashi, Kodaira, Tokyo
TEL	042-341-2712(6266)
Homepage URL
Email	s-kita@ncnp.go.jp

Sponsor
Institute	National Center of Neurology and Psychiatry
Institute
Department

Funding Source
Organization	MEXT(Japan)
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ethics Committee of the National Center of Neurology and Psychiatry
Address	4-1-1, Ogawa-Higashi, Kodaira, Tokyo
Tel	042-341-2712(7828)
Email	ml_rinrijimu@ncnp.go.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	2017 Year 01 Month 19 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	No longer recruiting
Date of protocol fixation	2016 Year 12 Month 21 Day
Date of IRB	2017 Year 01 Month 13 Day
Anticipated trial start date	2017 Year 01 Month 20 Day
Last follow-up date	2018 Year 02 Month 23 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 01 Month 19 Day
Last modified on	2019 Year 07 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029620