UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057650 |
|---|---|
| Receipt number | R000065869 |
| Scientific Title | Feasibility Assessments for Sleep Health Management by using a Wearable Device and Smartphone Applications in Workers |
| Date of disclosure of the study information | 2025/04/22 |
| Last modified on | 2025/04/18 11:20:31 |
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Basic information
Public title
Feasibility Study for Sleep Management by using a Wearable Device and Smartphone Applications in Workers
Acronym
Study of Sleep Management by using a Wearable Device and Smartphone Apps in Workers
Scientific Title
Feasibility Assessments for Sleep Health Management by using a Wearable Device and Smartphone Applications in Workers
Scientific Title:Acronym
Study of Sleep Health Management by using Wearable Devices and Smartphone Apps in Workers
Region
| Japan |
Condition
Condition
Adults who are daytime workers.
Classification by specialty
| Medicine in general | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose is to evaluate the feasibility and usefulness of sleep habit management using a smartphone application and API and a wearable device (Fitbit Inspire3,Google LLC) equivalent to the sleep check sheet based on the Sleep Guide for Health 2023, targeting day shift workers. The primary outcome measures are daytime performance (presenteeism) and quality of life. By examining the association between these outcomes and the usage pattern (i.e. frequency) of the smartphone application and API and the wearable device.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Work Limitations Questionnaire Short-Form Japanese version (WLQ-SF-J) score, 8-Item Short-Form Health Survey-Japanese (SF-8-J) score
Key secondary outcomes
Sleep habits (by evaluated with Sleep Check Sheet and smartphone app and API), sleep data measured by the wearable device, bedroom environments (temperature, humidity, illuminance, atmospheric pressure, noise, vibration, eTVOC), general health examination data (height, weight, BMI, waist circumference, visual acuity, blood pressure, smoking, drinking habits, alcohol consumption, chest X-ray findings, urinary protein, urinary glucose, urobilinogen, fecal occult blood, red blood cell count, hemoglobin, hematocrit, platelet count, MCH, MCV, MCHC, white blood cell count, total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides, AST, ALT, gamma-glutamyltransferase, ALP, LDH, TP, Alb, BUN, creatinine, eGFR, uric acid, fasting blood glucose, HbA1c, etc.), self-efficacy scale score
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
Wearable device (Fitbit Inspire 3) and smartphone app./API usage groups
1.Manage one's sleep time by using the wearable device with the Fitbit app.
2.Manage one's sleep habits using an original smartphone app. that has a function to provide feedback on habits in accordance with the sleep check sheet once a week.
The above management will be conducted for approximately 6 months.
Interventions/Control_2
Smartphone app./API only usage group
Manage one's sleep habits using an original smartphone app. that has a function to provide feedback on habits in accordance with the sleep check sheet once a week.
The above management will be conducted for approximately 6 months.
Interventions/Control_3
Wearable device (Fitbit Inspire 3) and smartphone app./API usage groups
Manage one's sleep time by using the wearable device with the Fitbit app.
The above management will be conducted for approximately 6 months
Interventions/Control_4
Neither wearable device nor smartphone app usage group (control group)
Participants in the group does not use a wearable device and the smartphone app. for managing sleep habits.
The above condition will be maintained for about 6 months.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Workers belonging to local governments, companies, or other organizations that have agreed to participate in the study and who have given their consent to this study.
Key exclusion criteria
1. Individuals who do not own a smartphone
2. Individuals engaged in shift work
3. Individuals who often take overseas business trips with time differences
4. Individuals who are already routinely using wearable devices, including Fitbit, for sleep management and cannot follow instructions to change or stop using their wearable device
5. Others whom the principal investigator or research director deems inappropriate
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Kenichi |
| Middle name | |
| Last name | Kuriyama |
Organization
National Center of Neurology and Psychiatry
Division name
Department of Sleep-Wake Disorders, National Institute of Mental Health
Zip code
187-8551
Address
4-1-1 Ogawa-Higashi, Kodaira, Tokyo
TEL
0423462014
kenichik@ncnp.go.jp
Public contact
Name of contact person
| 1st name | Tomohiro |
| Middle name | |
| Last name | Utsumi |
Organization
National Center of Neurology and Psychiatry
Division name
Department of Sleep-Wake Disorders, National Institute of Mental Health
Zip code
187-8551
Address
4-1-1 Ogawa-Higashi, Kodaira, Tokyo
TEL
0423462014
Homepage URL
t-utsumi@ncnp.go.jp
Sponsor or person
Institute
National Center of Neurology and Psychiatry
Institute
Department
Personal name
Kenichi Kuriyama
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Center of Neurology and Psychiatry Ethics Committee
Address
4-1-1 Ogawa-Higashi, Kodaira, Tokyo
Tel
042-341-2712
rinri-jimu@ncnp.go.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
| 2025 | Year | 04 | Month | 22 | 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
| 2025 | Year | 02 | Month | 06 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 10 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 23 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Analysts are blinded in this study.
Management information
Registered date
| 2025 | Year | 04 | Month | 18 | Day |
Last modified on
| 2025 | Year | 04 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065869
