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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040547
Receipt No. R000046284
Scientific Title *internet-based individualized Cognitive Behavioral Therapy for Shift Work Sleep Disorder (empowered by Wellbeing and Burnout prediction)
Date of disclosure of the study information 2020/06/01
Last modified on 2020/05/27

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Basic information
Public title *internet-based individualized Cognitive Behavioral Therapy for Shift Work Sleep Disorder (empowered by Wellbeing and Burnout prediction)
Acronym Cognitive Behavioral Therapy for Shift Work Sleep Disorder
Scientific Title *internet-based individualized Cognitive Behavioral Therapy for Shift Work Sleep Disorder (empowered by Wellbeing and Burnout prediction)
Scientific Title:Acronym Cognitive Behavioral Therapy for Shift Work Sleep Disorder
Region
Japan

Condition
Condition healthy adult
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study is a feasibility study to test the hypothesis that "cognitive behavioral therapy to improve sleep, empowered by artificial intelligence will improve sleep, wellbeing, and reduce risk of burnout syndrome."
Basic objectives2 Others
Basic objectives -Others To collect data in order to establish an algorithm we plan to use in Step 3.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes changes in hours of sleep
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Sleep improvement program(app)
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
65 years-old >=
Gender Male and Female
Key inclusion criteria 1) Employee at Mie University hospital, emergency and critical care center.
2) Shift worker(8hour shift)
3) Pittsburgh sleep questionnaire index(PSQI) equal or more than 5
4) Written consent obtained from the medical worker at his or her free will.
Key exclusion criteria 1) Diagnosed for sleep related disorders such as sleep apnea syndrome, restless leg syndrome, narcolepsy etc.
2) Diagnosed for psychotic disorders such as depression, panic disorder, anxiety disorder, etc.
3) Pregnancy or possible pregnancy.
4) High risk for skin irritation such as contact dermatitis or other skin disease.
5) Inappropriate due to decision of principal investigator or co-investigator.
Target sample size 70

Research contact person
Name of lead principal investigator
1st name Motomu
Middle name
Last name Shimaoka
Organization Mie University
Division name department of molecular biology
Zip code 514-8507
Address Mie Edobashi 2-174
TEL 059-232-1111
Email motomushimaoka@gmail.com

Public contact
Name of contact person
1st name Kazumi
Middle name
Last name Nishimasu
Organization Mie University
Division name emergency and critical care center
Zip code 514-8507
Address Mie Edobashi 2-174
TEL 059-232-1111
Homepage URL
Email panda09@clin.medic.mie-u.ac.jp

Sponsor
Institute Mie University
Institute
Department

Funding Source
Organization Japan agency for medical research and development
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 Mie University
Address Mie Tsu Edobashi 2-174
Tel 059-232-1111
Email kk-sien@mo.medic.mie-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
2020 Year 06 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 Preinitiation
Date of protocol fixation
2020 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2020 Year 06 Month 01 Day
Last follow-up date
2022 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
2020 Year 05 Month 27 Day
Last modified on
2020 Year 05 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046284

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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