UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034642 |
|---|---|
| Receipt number | R000039381 |
| Scientific Title | The effects of sleep evaluation and behavior improvement supports on self-rated health and work productivity. |
| Date of disclosure of the study information | 2018/10/26 |
| Last modified on | 2019/04/25 11:11:12 |
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Basic information
Public title
The effects of sleep evaluation and behavior improvement supports on self-rated health and work productivity.
Acronym
The effects of sleep evaluation and behavior improvement supports on self-rated health and work productivity.
Scientific Title
The effects of sleep evaluation and behavior improvement supports on self-rated health and work productivity.
Scientific Title:Acronym
The effects of sleep evaluation and behavior improvement supports on self-rated health and work productivity.
Region
| Japan |
Condition
Condition
No (healthy adults)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of sleep evaluation and behavior improvement supports on self-rated health and work productivity,based on sleep evaluation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
-Sleep satisfaction
Key secondary outcomes
-Subjective and objective sleep quality
-Subjective health
-Subjective and objective fatigue/stress
-Subjective and objective work productivity
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food | Behavior,custom | Other |
Interventions/Control_1
Sleep evaluation and behavoir improvement supports for 2 weeks.
Interventions/Control_2
no intervention.
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
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
-Subjects who are full time daytime worker
-Subjects who sleep at night everyday.
-Subjects who understand the purpose and the plan of this study and consent to participate in the study.
Key exclusion criteria
-Subjects who work on the graveyard shift during study period.
-Subjects who are not sleep properly because of mental disorder, physical disorder or drug usage.
-Subjects who use a medicine related to sleep, fatigue or stress.
-Subjects who cannot stop to intake a food or quasi drug related to sleep, fatigue or stress.
-Subjects who have disease, who have to go to hospital routinely and who have to receive medical observation.
-Subjects who are sleep apnea syndrome or have either a possibility or medical history of sleep apnea syndrome.
-Subjects who are pregnant or lactating, or plan to become pregnant during the study period.
-Subjects who are participating or plan to participate in any other clinical trial during the study period.
-Subjects who are deemed inappropriate for this study by the principle investigator.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Megumi |
| Middle name | |
| Last name | Aono |
Organization
LION Corporation
Division name
Wellness research laboratories
Zip code
2560811
Address
100, Tajima, Odawara, Kanagawa, JAPAN
TEL
0465-49-4541
meg-y@lion.co.jp
Public contact
Name of contact person
| 1st name | Megumi |
| Middle name | |
| Last name | Aono |
Organization
LION Corporation
Division name
Wellness research laboratories
Zip code
2560811
Address
100, Tajima, Odawara, Kanagawa, JAPAN
TEL
0465-49-4541
Homepage URL
meg-y@lion.co.jp
Sponsor or person
Institute
LION Corporation
Institute
Department
Personal name
Funding Source
Organization
LION Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
RIKEN
Name of secondary funder(s)
Ministry of Economy, Trade and Industry
IRB Contact (For public release)
Organization
LION Corporation
Address
100, Tajima, Odawara, Kanagawa, JAPAN
Tel
0465-48-3211
meg-y@lion.co.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
K2018-031
Org. issuing International ID_1
RIKEN
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 10 | Month | 26 | 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
109
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
| 2018 | Year | 10 | Month | 10 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 12 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 26 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 10 | Month | 25 | Day |
Last modified on
| 2019 | Year | 04 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039381
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
