UMIN-CTR Clinical Trial

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

Contact us.