Tokyo, April 8 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061189) titled 'Effects of AI-Based Personalized Sleep Feedback in High School Female Soccer Players' on April 7.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -but assessor(s) are blinded Control - Active

Primary Sponsor: Institute - Nippon Sport Science University Medical Vocational School

Condition: Condition - Sleep problems in high school female soccer players Classification by malignancy - Others Genomic information - NO

Objective: 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

Intervention: 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.

Eligibility: Age-lower limit - 15 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 Size - 25

Recruitment Status: 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

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070024

Disclaimer: Curated by HT Syndication.