UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000048773 |
|---|---|
| Receipt number | R000055566 |
| Scientific Title | Development of a digital support system to improve the quality of sleep for medical professionals |
| Date of disclosure of the study information | 2022/08/27 |
| Last modified on | 2023/08/27 10:44:16 |
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Basic information
Public title
Development of a digital support system to improve the quality of sleep for medical professionals
Acronym
digital supporting system for sleep
Scientific Title
Development of a digital support system to improve the quality of sleep for medical professionals
Scientific Title:Acronym
digital supporting system for sleep
Region
| Japan |
Condition
Condition
qality of sleep
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the sleep status of medical personnel
Basic objectives2
Others
Basic objectives -Others
Identifying factors that affect sleep quality in healthcare professionals.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sleep score
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Persons who are 18 years of age or older
2) Who can give consent to participate in the study
3) Who are able to use the Fitbit
Key exclusion criteria
1) When the subject is unable to use a smartphone
2) When the use of Fitbit is a burden to the subject
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Tomohiro |
| Middle name | |
| Last name | Ishinuki |
Organization
Sapporo Medical University
Division name
Graduate School of Health Sciences
Zip code
0608556
Address
W-17, S-1, Chuo-ku, Sapporo, Hokkaido, Japan
TEL
0116112111
tomohiro-ishi@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | Tomohiro |
| Middle name | |
| Last name | Ishinuki |
Organization
Sapporo Medical University
Division name
Graduate School of Health Sciences
Zip code
0608556
Address
W-17, S-1, Chuo-ku, Sapporo, Hokkaido, Japan
TEL
0116112111
Homepage URL
tomohiro-ishi@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
Sapporo Medical University ethics committee
Address
W-17, S-1, Chuo-ku, Sapporo, Hokkaido, Japan
Tel
0116112111
tetsuya.tamada@sapmed.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
| 2022 | Year | 08 | Month | 27 | 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
60
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
Main results already published
Date of protocol fixation
| 2022 | Year | 04 | Month | 30 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 16 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2025 | Year | 04 | Month | 03 | Day |
Date analysis concluded
| 2025 | Year | 12 | Month | 31 | Day |
Other
Other related information
Conduct observation of sleep conditions using Fitbit and questionnaires
Management information
Registered date
| 2022 | Year | 08 | Month | 26 | Day |
Last modified on
| 2023 | Year | 08 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055566
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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