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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | healthy adult | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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. |
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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. |
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Target sample size | 70 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |