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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

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 - AI Sleep Intervention Pilot RCT

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000061189
Enrollment
25
Registered
2026-04-07
Start date
2025-08-18
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep problems in high school female soccer players

Interventions

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 b

Sponsors

Nippon Sport Science University Medical Vocational School
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
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.

Countries

Japan

Contacts

Public ContactHayato Kedoin

Nippon Sport Science University Medical Vocational School Department of Judo Therapy and Health Science

kedoin@nittai-iryo.ac.jp08064188981

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026