UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060439 |
|---|---|
| Receipt number | R000069143 |
| Scientific Title | Effects of a digital behavior modification app targeting sleep debt on work performance and mental health: a randomized controlled trial |
| Date of disclosure of the study information | 2026/01/22 |
| Last modified on | 2026/01/22 12:54:52 |
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Basic information
Public title
Effects of a digital behavior modification app targeting sleep debt on work performance and mental health: a randomized controlled trial
Acronym
Effects of a digital behavior modification app targeting sleep debt: a randomized controlled trial
Scientific Title
Effects of a digital behavior modification app targeting sleep debt on work performance and mental health: a randomized controlled trial
Scientific Title:Acronym
Effects of a digital behavior modification app targeting sleep debt: a randomized controlled trial
Region
| Japan |
Condition
Condition
Daytime workers with sleep debt
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to examine whether a digital behavior modification app designed to improve sleep debt leads to improvements in sleep problems, productivity, and mental health among workers.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
total sleep time, RSQ (Restoring Sleep Questionnaire), SPQ (Single-item Presenteeism Questionnaire)
Key secondary outcomes
AIS (Athens Insomnia Scale), SHS (Subjective Happiness Scale), WHO-5
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Digital behavior modification app group
Interventions/Control_2
Wait-list control
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Daytime workers
Individual with sleep debt
Key exclusion criteria
Shift-workers
Individuals who are currently under treatment for chronic physical illnesses, mental disorders, or sleep disorders
Target sample size
124
Research contact person
Name of lead principal investigator
| 1st name | Isa |
| Middle name | |
| Last name | Okajima |
Organization
Tokyo Kasei University
Division name
Department of Psychological Counseling
Zip code
173-8602
Address
1-18-1 Kaga, Itabashi-ku, Tokyo
TEL
03-3961-5276
okajima-i@tokyo-kasei.ac.jp
Public contact
Name of contact person
| 1st name | Isa |
| Middle name | |
| Last name | Okajima |
Organization
Tokyo Kasei University
Division name
Department of Psychological Counseling
Zip code
173-8602
Address
1-18-1 Kaga, Itabashi-ku, Tokyo
TEL
03-3961-5276
Homepage URL
okajima-i@tokyo-kasei.ac.jp
Sponsor or person
Institute
Tokyo Kasei University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Kasei University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Kasei University
Address
1-18-1 Kaga, Itabashi-ku, Tokyo
Tel
03-3961-5276
okajima-i@tokyo-kasei.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
| 2026 | Year | 01 | 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 | 10 | Month | 01 | Day |
Date of IRB
| 2026 | Year | 01 | Month | 15 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 26 | Day |
Last follow-up date
| 2026 | Year | 07 | 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
| 2026 | Year | 01 | Month | 22 | Day |
Last modified on
| 2026 | Year | 01 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069143
