UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063634 |
|---|---|
| Receipt number | R000072827 |
| Scientific Title | Effects of Generative AI-Based Sleep Education on Sleep Hygiene Practices and Sleep Habits Among Medical Vocational School Students |
| Date of disclosure of the study information | 2026/11/15 |
| Last modified on | 2026/11/15 08:17:06 |
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Basic information
Public title
Effects of AI-Generated Sleep Advice on Sleep Habits in Medical Vocational School Students
Acronym
AI Sleep Education Study
Scientific Title
Effects of Generative AI-Based Sleep Education on Sleep Hygiene Practices and Sleep Habits Among Medical Vocational School Students
Scientific Title:Acronym
AI Sleep Education Trial in Medical Vocational Students
Region
| Japan |
Condition
Condition
Problems in sleep hygiene practices and sleep habits
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of personalized sleep education generated by artificial intelligence using Fitbit-derived sleep data on sleep hygiene practices, subjective sleep quality, sleep duration, sleep efficiency, sleep regularity, and psychological status among medical vocational school students, compared with provision of numerical sleep metrics alone.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Primary outcome: Change in the total score of the Japanese Sleep Hygiene Practice Scale (SHPS-J) from the pre-intervention questionnaire administered on 4 November 2026 to the post-observation questionnaire scheduled for 14 December 2026. Multiple linear regression will compare change scores between trial arms, adjusting for academic year and baseline SHPS-J total score; adjusted between-group difference, 95% CI, and two-sided p value (alpha=0.05) will be reported.
Key secondary outcomes
Secondary outcomes: Japanese PSQI (pre-assessment on 4 Nov 2026; post-assessment planned for 14 Dec 2026), and Fitbit-derived sleep duration, sleep efficiency, and Sleep Regularity Index across the 35-night measurement period (9 Nov-13 Dec 2026). Exploratory outcome: Japanese DASS-21 assessed on 4 Nov and planned for 14 Dec 2026.
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
No need to know
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention arm: Participants wear Fitbit Inspire 3 and, from 16 Nov to 6 Dec 2026 (21 days), receive sleep metrics and personalized generative AI-based sleep education via LINE, typically once per day after morning data synchronization. Feedback addresses sleep hygiene, sleep quality and sleep-wake regularity with actionable suggestions for medical vocational students. In the public code, the synchronization/delivery process is polled every 15 minutes from 06:00 to 10:45 JST, without a guaranteed fixed delivery time. Agreement with production settings and delivery logs has not been verified. Neutral sync/wear reminders are not considered the education intervention. Handling of missing or unsynchronized data will be checked against production logs.
Interventions/Control_2
Control arm: From 16 Nov to 6 Dec 2026, participants receive only numerical Fitbit-derived sleep metrics (including bedtime, wake time, sleep duration and sleep efficiency) via LINE, typically once daily after morning synchronization, without interpretation, sleep hygiene advice, encouragement or behavioral recommendations. No AI sleep education is delivered to either group during baseline (9-15 Nov 2026) or post-observation (7-13 Dec 2026). Delayed educational feedback for the control group is planned after all assessments.
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
Second- or third-year students enrolled in the Department of Judo Therapy and Health Science or the Department of Oral Health at Nippon Sport Science University Medical Vocational School who have received an explanation of the study and voluntarily provided informed consent.
Key exclusion criteria
No specific exclusion criteria.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Hayato |
| Middle name | |
| Last name | Kedoin |
Organization
Nippon Sport Science University Medical Vocational School
Division name
Department of Judo Therapy and Health Science
Zip code
158-0097
Address
2-2-7 Yoga, Setagaya-ku, Tokyo 158-0097, Japan
TEL
03-5717-6161
kedoin@nittai-iryo.ac.jp
Public contact
Name of contact person
| 1st name | Hayato |
| Middle name | |
| Last name | Kedoin |
Organization
Nippon Sport Science University Medical Vocational School
Division name
Department of Judo Therapy and Health Science
Zip code
158-0097
Address
2-2-7 Yoga, Setagaya-ku, Tokyo 158-0097, Japan
TEL
03-5717-6161
Homepage URL
kedoin@nittai-iryo.ac.jp
Sponsor or person
Institute
Nippon Sport Science University Medical Vocational School
Institute
Department
Personal name
Funding Source
Organization
Metropolitan Foundation for Private Schools
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee, Nippon Sport Science University Medical Vocational School
Address
2-2-7 Yoga, Setagaya-ku, Tokyo 158-0097, Japan
Tel
03-5717-6161
info@nittai-iryo.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
日本体育大学医療専門学校（東京都）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 11 | Month | 15 | 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
40
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
Individual participant data (IPD) will not be made available for public sharing.
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2026 | Year | 05 | Month | 26 | Day |
Date of IRB
| 2026 | Year | 09 | Month | 17 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 30 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2026 | Year | 12 | Month | 28 | Day |
Other
Other related information
The first participant provided informed consent on 30 October 2026, and Fitbit-based baseline monitoring began on 9 November 2026, before registration in UMIN-CTR. This is therefore a retrospective registration. The study was approved by the Research Ethics Committee of Nippon Sport Science University Medical Vocational School on 17 September 2026 (approval No. 026-004). Recruitment has been completed, with 40 enrolled participants; the trial is ongoing.
Participants comprise 17 second-year and 23 third-year students. Individual randomization using stratified permuted blocks of varying sizes by academic year is planned for 16 November 2026, targeting a 1:1 allocation ratio. Exact 1:1 balance within the odd-sized strata or 20:20 overall is not guaranteed. An independent faculty member not involved in intervention, assessment or analysis generates and separately holds the allocation list. The study system automatically delivers group-specific messages. The analyst remains masked to the group-code mapping until the primary analysis is finalized.
Randomized participants will constitute the ITT population, but the primary analysis will be a complete-case analysis of participants with both pre- and post-assessment SHPS-J scores. Sensitivity analyses are planned to assess the impact of missing data; specific methods remain to be determined.
Management information
Registered date
| 2026 | Year | 11 | Month | 15 | Day |
Last modified on
| 2026 | Year | 11 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072827
