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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033976
Receipt No. R000038297
Scientific Title The development of sleeping support system in order to improve the sleep conditions based on relationship between worker 's stress and sleeplessness for the improvement of a self-care ability
Date of disclosure of the study information 2018/09/01
Last modified on 2019/03/05

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Basic information
Public title The development of sleeping support system in order to improve the sleep conditions based on relationship between worker 's stress and sleeplessness for the improvement of a self-care ability
Acronym The development of sleeping support system in order to improve the sleep conditions based on relationship between worker 's stress and sleeplessness for the improvement of a self-care ability
Scientific Title The development of sleeping support system in order to improve the sleep conditions based on relationship between worker 's stress and sleeplessness for the improvement of a self-care ability
Scientific Title:Acronym The development of sleeping support system in order to improve the sleep conditions based on relationship between worker 's stress and sleeplessness for the improvement of a self-care ability
Region
Japan

Condition
Condition Sleeplessness
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The research aim is to monitor and follow up the daily amount of activity and sleep conditions, in order to improve a self-care capacity by using an activity level surveying instrument.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes The score of the Athens insomnia measure after three months.
Key secondary outcomes The Brief Job Stress Questionnaire

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 After wearing the activity meter for 2 weeks, we provide guidance on sleep hygiene by individual consultation and wear activity meter for 2 more weeks
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
22 years-old <=
Age-upper limit
65 years-old >
Gender Male and Female
Key inclusion criteria Those interested in sleeping
Key exclusion criteria Those diagnosed with insomnia
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Michiko Watanabe
Organization NIIGATA SEIRYO UNIVERSITY
Division name Department of nursing
Zip code
Address 1-5939, Suidocho, Chuo-ku, Niigata
TEL 0252669538
Email miwatanabe@n-seiryo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Michiko Watanabe
Organization Niigata seiryo university
Division name Department of nursing
Zip code
Address 1-5939 suidoucho chuo-ku niigata
TEL 0252669538
Homepage URL
Email miwatanabe@n-seiryo.ac.jp

Sponsor
Institute Niigata seiryo university
Institute
Department

Funding Source
Organization Niigata seiryo university
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
Address
Tel
Email

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
2018 Year 09 Month 01 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 Enrolling by invitation
Date of protocol fixation
2018 Year 08 Month 17 Day
Date of IRB
Anticipated trial start date
2018 Year 08 Month 20 Day
Last follow-up date
2019 Year 12 Month 31 Day
Date of closure to data entry
2020 Year 01 Month 31 Day
Date trial data considered complete
2020 Year 02 Month 29 Day
Date analysis concluded
2020 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2018 Year 08 Month 31 Day
Last modified on
2019 Year 03 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038297

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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