UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040547 |
|---|---|
| Receipt number | 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 | 2022/08/01 15:00:34 |
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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
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
panda09@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
Mie University
Institute
Department
Personal name
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
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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 05 | Day |
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
| 2022 | Year | 08 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046284
