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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000046127
Receipt No. R000052651
Scientific Title Effect of sleep quality on physiological indices in evacuees
Date of disclosure of the study information 2021/11/20
Last modified on 2021/11/20

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Basic information
Public title Effect of sleep quality on physiological indices in evacuees
Acronym Effect of sleep quality on physiological indices in evacuees
Scientific Title Effect of sleep quality on physiological indices in evacuees
Scientific Title:Acronym Effect of sleep quality on physiological indices in evacuees
Region
Japan

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

Objectives
Narrative objectives1 The purpose of this study is to objectively and subjectively evaluate the sleep of evacuees in an experimental environment simulating overnight stays in a car during a disaster, and to clarify the effects of different sleep environments on work efficiency.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Quality of sleep, sleep feeling, and work efficiency
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Educational,Counseling,Training
Type of intervention
Other
Interventions/Control_1 car trial (car seat 45)
Interventions/Control_2 car trial (car seat 60)
Interventions/Control_3 home trial
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
30 years-old >
Gender Male
Key inclusion criteria People without sleep disorders
Key exclusion criteria Smokers
People who are engaged in shift work
People who are taking medication
People who have back pain
Target sample size 15

Research contact person
Name of lead principal investigator
1st name Hitomi
Middle name
Last name Ogata
Organization Hiroshima University
Division name Graduate School of Humanities and Social Sciences
Zip code 7398521
Address 1-7-1 Kagamiyama, Higashi-Hiroshima, Hiroshima, Japan
TEL 082-424-6589
Email hogata@hiroshima-u.ac.jp

Public contact
Name of contact person
1st name Hitomi
Middle name
Last name Ogata
Organization Hiroshima University
Division name Graduate School of Humanities and Social Sciences
Zip code 7398521
Address 1-7-1 Kagamiyama, Higashi-Hiroshima, Hiroshima, Japan
TEL 082-424-6589
Homepage URL
Email hogata@hiroshima-u.ac.jp

Sponsor
Institute Hiroshima University
Institute
Department

Funding Source
Organization Career Advancement Project for Women Researchers (CAPWR), Hiroshima University (2019)

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 Hiroshima University
Address 1-7-1 Kagamiyama, Higashi-Hiroshima, Hiroshima, Japan
Tel 082-424-6589
Email hogata@hiroshima-u.ac.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
2021 Year 11 Month 20 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 15
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
2019 Year 10 Month 31 Day
Date of IRB
2019 Year 11 Month 13 Day
Anticipated trial start date
2019 Year 11 Month 15 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 11 Month 20 Day
Last modified on
2021 Year 11 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052651

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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