UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061189 |
|---|---|
| Receipt number | R000070024 |
| Scientific Title | Feasibility and Preliminary Effects of Mobile AI-Generated Personalized Sleep Feedback Based on Objective Sleep Metrics Among High School Female Soccer Players: Pilot Randomized Controlled Trial |
| Date of disclosure of the study information | 2026/04/07 |
| Last modified on | 2026/05/02 10:14:57 |
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Basic information
Public title
Feasibility and Preliminary Effects of Mobile AI-Generated Personalized Sleep Feedback Based on Objective Sleep Metrics Among High School Female Soccer Players: Pilot Randomized Controlled Trial
Acronym
AI Sleep Feedback Trial
Scientific Title
Feasibility and Preliminary Effects of Mobile AI-Generated Personalized Sleep Feedback Based on Objective Sleep Metrics Among 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 was to evaluate the feasibility of mobile AI-generated personalized sleep feedback based on objective sleep metrics among high school female soccer players and to explore preliminary effects on sleep-related outcomes, mood state, and sports injury-related burden, with sleep efficiency specified as the main preliminary efficacy outcome.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The main preliminary efficacy outcome was sleep efficiency measured using Fitbit Inspire 3. Change was calculated from the mean value during the baseline observation period (weeks 1-4) to the mean value during the intervention period (weeks 6-9), and change scores were compared between the intervention and control groups.
Key secondary outcomes
Secondary and exploratory outcomes included total sleep time, wake after sleep onset, deep sleep duration, light sleep duration, rapid eye movement sleep duration measured using Fitbit Inspire 3, the Pittsburgh Sleep Quality Index Japanese version (PSQI-J) total score, the Sleep Difficulty Score of the Athlete Sleep Screening Questionnaire Japanese version (ASSQ-J), the Japanese version of the Epworth Sleepiness Scale (JESS) total score, the Total Mood Disturbance score of the Japanese version of the Profile of Mood States 2nd Edition, and sports injury-related burden/severity assessed using a modified OSTRC-H-J. Questionnaire-based outcomes were assessed at week 5 and week 10. Feasibility outcomes included LINE message delivery success rate, number of valid Fitbit wear nights, questionnaire completion rate, technical problems, adverse events, and privacy-related problems.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is 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 weeks 6 to 9, personalized sleep feedback generated by ChatGPT-4o was delivered via the LINE Messaging API based on Fitbit Inspire 3 sleep data from the previous night and baseline mean values for each participant. Feedback was delivered only on days when valid sleep data from the previous night were available.
Interventions/Control_2
Control group: As an attention control, participants received general and nonpersonalized sleep-related information via LINE once daily at 8:00 AM during the 4-week intervention period (weeks 6 to 9). The content was limited to general sleep hygiene, the role of sleep, general knowledge for athletes, environmental adjustment, and relaxation strategies, and did not include personalized advice based on individual Fitbit data, subjective condition, training status, or previous responses.
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
1580097
Address
2-2-7 Yoga, Setagaya-ku, Tokyo 158-0097, 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
1580097
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 completed the trial. Delivery and questionnaire completion rates were 100%. No major technical problems, adverse events, or privacy breaches occurred. Exploratory analyses showed favorable between-group differences in sleep efficiency, REM sleep duration, PSQI-J, Sleep Difficulty Score, and TMD. No clear differences were found in total sleep time, daytime sleepiness, or injury-related burden. Findings are hypothesis-generating.
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 high school female soccer players with a mean age of 16.93 years (SD 0.70) and a mean playing experience of 9.61 years (SD 2.14). 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 adverse events related to the intervention or device use were observed in this study. No privacy breaches, including leakage of personal information, occurred.
Outcome measures
The primary outcome was sleep efficiency as the main preliminary efficacy outcome. Secondary and exploratory outcomes were total sleep time, wake after sleep onset, deep sleep duration, light sleep duration, rapid eye movement sleep duration, PSQI-J total score, the Sleep Difficulty Score of the ASSQ-J, JESS total score, Total Mood Disturbance score, and sports injury-related burden/severity 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. Feasibility outcomes included LINE message delivery success rate, number of valid Fitbit wear nights, questionnaire completion rate, technical problems, adverse events, and privacy-related problems.
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 | 18 | Day |
Last follow-up date
| 2025 | Year | 11 | Month | 03 | 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 | 05 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070024
