UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061170 |
|---|---|
| Receipt number | R000069965 |
| Scientific Title | Effects of AI-based advice on sleep debt reduction |
| Date of disclosure of the study information | 2026/04/07 |
| Last modified on | 2026/04/03 09:50:14 |
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Basic information
Public title
Effects of AI-based advice on sleep debt reduction
Acronym
Sleep Debt Improvement App RCT
Scientific Title
Effects of AI-based advice on sleep debt reduction
Scientific Title:Acronym
Sleep Debt Improvement App RCT
Region
| Japan |
Condition
Condition
Healthy adults with sleep debt
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To exploratorily evaluate the effects of self-state visualization and feedback provided by an AI-based application for sleep debt reduction on sleep debt alleviation, subjective sleep quality improvement, mental health, and work productivity in working-age adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Total score of the sleep debt assessment questionnaire,
Key secondary outcomes
Pittsburgh Sleep Quality Index (PSQI) total score; Single-Item Presenteeism Question (SPQ); K6 Japanese version total score. Other outcomes: Sleep Debt Index (SDI), sleep restfulness (single Likert scale), Karolinska Sleepiness Scale Japanese (KSS-J), PVT-B-based game objective sleepiness (lapses, mean 1/RT), ME-BYO index.
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
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Sleep debt reduction app group(<=39 years-old)
Interventions/Control_2
Wait-list group(<=39 years-old)
Interventions/Control_3
Sleep debt reduction app group (>=40 years-old )
Interventions/Control_4
Wait-list group( >=40 years-old)
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
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Aged 18-59 years (2) Sleep debt assessment questionnaire score of 3-18
Key exclusion criteria
(1) Persons with obstructive sleep apnea, insomnia, or restless legs syndrome (2) Under treatment for chronic diseases (3) Taking sleep medications (4) Shift/night/part-time/short-time workers, or <=2 days/week remote work (5) Traveled to region with >=2h time difference in past 2 weeks (6) Caring for infants, pregnant, menopausal, or providing caregiving (7) Others deemed inappropriate by PI or sub-investigator
Target sample size
216
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Abe |
Organization
University of Tsukuba
Division name
International Institute for Integrative Sleep Medicine (WPI-IIIS), Tsukuba Institute for Advanced Research (TIAR)
Zip code
305-8577
Address
1-1-1, Tennodai, Tsukuba, Ibaraki, Japan
TEL
029-859-1858
abe.takashi.gp@u.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Mitsuhiro |
| Middle name | |
| Last name | Matsumoto |
Organization
Nemielu,inc.
Division name
CEO
Zip code
163-1302
Address
Shinjuku i-Land Tower 2F 6-5-1 Nishi-Shinjuku,Shinjuku-ku Tokyo 163-1302, Japan
TEL
070-4321-4215
Homepage URL
info@nemielu.com
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Nemielu,inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee, Faculty of Medicine, University of Tsukuba
Address
1-1-1 Tennodai, Tsukuba, Ibaraki
Tel
029-853-3022
sien.ningenss@un.tsukuba.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 | 04 | Month | 07 | 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
| 2026 | Year | 03 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 08 | Month | 30 | 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 | 04 | Month | 06 | Day |
Last modified on
| 2026 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069965
