UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046127 |
|---|---|
| Receipt number | 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 12:16:31 |
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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
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
hogata@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052651
