UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061189 |
|---|---|
| Receipt number | R000070024 |
| Scientific Title | Effects of Personalized Feedback Generated by Generative Artificial Intelligence Based on Objective Sleep Metrics on Sleep, Mood States, and Sports Injury Severity in High School Female Soccer Players: Pilot Randomized Controlled Trial |
| Date of disclosure of the study information | 2026/04/07 |
| Last modified on | 2026/04/07 21:55:10 |
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Basic information
Public title
Effects of AI-Based Personalized Sleep Feedback in High School Female Soccer Players
Acronym
AI Sleep Feedback Trial
Scientific Title
Effects of Personalized Feedback Generated by Generative Artificial Intelligence Based on Objective Sleep Metrics on Sleep, Mood States, and Sports Injury Severity in High School Female Soccer Players: Pilot Randomized Controlled Trial
Scientific Title:Acronym
AI Sleep Intervention Pilot RCT
Region
| Japan |
Condition
Condition
Sleep problems in high school female soccer players
Classification by specialty
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to investigate the effects of personalized feedback generated by generative artificial intelligence based on objective sleep metrics on sleep, mood states, and sports injury severity in high school female soccer players.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Sleep efficiency measured by Fitbit Inspire 3. Change from the mean value during the baseline observation period (weeks 1-4) to the mean value during the intervention period (weeks 6-9).
Key secondary outcomes
Total sleep time, wake after sleep onset, deep sleep duration, light sleep duration, and rapid eye movement sleep duration, all measured by Fitbit Inspire 3 and compared between the mean values during weeks 1-4 and weeks 6-9; total score of the Pittsburgh Sleep Quality Index Japanese version (PSQI-J); Sleep Difficulty Score; total score of the Japanese version of the Epworth Sleepiness Scale (ESS-J); Total Mood Disturbance score of the Japanese version of the Profile of Mood States 2nd Edition; and sports injury severity score assessed using a modified Japanese version of the Oslo Sports Trauma Research Center questionnaire on health problems. Questionnaire-based outcomes were assessed at week 5 and week 10.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
NO
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 group: During the 4-week intervention period (weeks 6 to 9), personalized sleep feedback generated by ChatGPT-4o was delivered once daily via the LINE Messaging API based on the previous night's Fitbit Inspire 3 sleep metrics (eg, total sleep time, bedtime, wake time, sleep efficiency, and sleep stages) and each participant's mean values during the baseline observation period (weeks 1 to 4). Delivery was automatically triggered after morning Fitbit data synchronization and was generally provided once each morning before the participant started daily activities.
Interventions/Control_2
Control group: During the 4-week intervention period (weeks 6 to 9), general and nonpersonalized sleep-related information was delivered once daily via LINE. The contents were limited to basic sleep hygiene, the role of sleep, and general knowledge for athletes (eg, environmental adjustment and relaxation strategies), and did not include advice based on individual sleep data. Messages were delivered every morning at 8:00 AM.
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
| 15 | years-old | <= |
Age-upper limit
| 18 | years-old | >= |
Gender
Female
Key inclusion criteria
Female soccer players belonging to a high school sports club who were expected to continue regular training and matches during the study period. Participants were required to be able to wear Fitbit Inspire 3 and receive messages via LINE, and to provide assent with written parental consent after receiving an explanation of the study.
Key exclusion criteria
Participants were excluded if they were expected to be absent for a prolonged period during the study, were unable to wear Fitbit Inspire 3 continuously, were unable to receive messages continuously via LINE, or were considered unsuitable for participation by the principal investigator.
Target sample size
25
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
2270034
Address
New Sophia 307, 1-11-19 Katsuradai, Aoba-ku, Yokohama, Kanagawa, Japan
TEL
08064188981
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
2270034
Address
2-2-7 Yoga, Setagaya-ku, Tokyo 158-0097, Japan
TEL
08064188981
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
Nippon Sport Science 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
Research Ethics Committee of Nippon Sport Science University
Address
7-1-1 Fukasawa, Setagaya-ku, Tokyo, Japan
Tel
08064188981
kedohayato1004@gmail.com
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
25
Results
All 25 participants were included in the final analysis. Compared with the control group, the intervention group showed significant improvements in changes in sleep efficiency, rapid eye movement sleep duration, total PSQI-J score, Sleep Difficulty Score, and Total Mood Disturbance. In contrast, no significant between-group differences were observed in total sleep time, wake after sleep onset, deep sleep duration, light sleep duration, daytime sleepiness, or sports injury severity score.
Results date posted
| 2026 | Year | 04 | Month | 07 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participants were 25 female high school soccer players with a mean age of 16.5 years (SD 0.7). After randomization, 12 participants were allocated to the intervention group and 13 to the control group. At baseline, there were no significant between-group differences in demographic characteristics or any outcome measures.
Participant flow
A total of 25 participants were enrolled before study initiation. After randomization, 12 participants were assigned to the intervention group and 13 to the control group. There were no dropouts during the study period, and all 25 participants were included in the final analysis.
Adverse events
No serious adverse events related to the intervention were reported in this study.
Outcome measures
The primary outcome was sleep efficiency. Secondary outcomes were total sleep time, wake after sleep onset, deep sleep duration, light sleep duration, rapid eye movement sleep duration, total PSQI-J score, Sleep Difficulty Score, total ESS-J score, Total Mood Disturbance score, and sports injury severity score assessed using a modified OSTRC-H-J. Objective sleep metrics were continuously measured using Fitbit Inspire 3, and questionnaire-based assessments were conducted at week 5 and week 10.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2025 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 20 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 01 | 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 | 07 | Day |
Last modified on
| 2026 | Year | 04 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070024
