UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000025744
Receipt No. R000029620
Scientific Title Understanding the health effects and susceptibility factors of circadian misaligngment
Date of disclosure of the study information 2017/01/19
Last modified on 2019/07/23

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.