Feasibility and Preliminary Effects of AI-Generated Personalized Sleep Feedback in High School Female Soccer Players: Pilot Randomized Controlled Trial.

IF 2.4 Q3 HEALTH CARE SCIENCES & SERVICES
Hayato Kedoin, Yuzuru Itoh, Takumi Nirengi, Yuji Sato, Shun Sugisawa, Yusuke Nishio, Ryo Akitsu
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引用次数: 0

Abstract

Background: Adequate sleep supports mood regulation and injury prevention in high school female athletes; however, insufficient sleep is common in this population. Wearable devices enable continuous assessment of objective sleep metrics, but personalized feedback based on daily sleep data remains underexplored.

Objective: This study evaluated the technical and operational feasibility of a multicomponent AI-supported mobile health (mHealth) intervention that delivered personalized sleep feedback to high school female soccer players. Sleep efficiency was the primary preliminary efficacy outcome; other sleep-related measures were secondary or exploratory outcomes, and mood state and sports injury severity were exploratory outcomes.

Methods: We conducted a pilot randomized controlled trial among 25 high school female soccer players from a single team. The study briefing and system setup began on August 18, 2025, and the trial was retrospectively registered with the University Hospital Medical Information Network (UMIN) Clinical Trials Registry on April 7, 2026 (UMIN000061189). Weeks 1 to 4 constituted the baseline period. After the week 5 baseline questionnaires, participants were stratified by median baseline total sleep time (TST) and Pittsburgh Sleep Quality Index score and randomly allocated 1:1 to the intervention (n=12) or control (n=13) group. During weeks 6 to 9, the intervention group received GPT-4o-generated personalized feedback via LINE on days with valid prior-night Fitbit data, whereas the control group received daily nonpersonalized sleep information. Technical and operational feasibility outcomes included message delivery success, valid Fitbit wear nights, questionnaire completion, technical problems, adverse events, and privacy breaches. Secondary outcomes included TST, wake after sleep onset (WASO), subjective sleep quality, sleep difficulty, and daytime sleepiness. Deep, light, and rapid eye movement (REM) sleep durations, mood state, and sports injury severity were exploratory outcomes.

Results: All 25 participants completed the trial. Message delivery success and questionnaire completion were 100% in both groups. Median valid Fitbit wear nights were 26 (IQR 24-28) in the intervention group and 22 (IQR 15-26) in the control group. No major technical problems, adverse events, or privacy breaches occurred. Change in sleep efficiency, the primary preliminary efficacy outcome, favored the intervention group (Hodges-Lehmann between-group difference 2%, 95% CI 0.50%-4%; P=.046; r=0.35). Nominal between-group differences were also observed for the Japanese version of the Pittsburgh Sleep Quality Index (PSQI-J) total score and sleep difficulty score and, among exploratory outcomes, REM sleep duration and total mood disturbance. No between-group differences were observed in TST, WASO, deep or light sleep duration, daytime sleepiness, or sports injury severity.

Conclusions: The multicomponent AI-supported mHealth intervention demonstrated technical and operational feasibility in this single-team setting. Preliminary, hypothesis-generating between-group differences were observed in sleep efficiency and selected subjective sleep and mood outcomes. These findings should not be interpreted as evidence of established effectiveness and require confirmation in a sufficiently powered trial.

Trial registration: UMIN Clinical Trials Registry UMIN000061189; https://tinyurl.com/tw3d7aku.

人工智能生成个性化睡眠反馈在高中女足运动员中的可行性及初步效果:先导随机对照试验。
背景:充足的睡眠支持高中女运动员的情绪调节和伤害预防;然而,睡眠不足在这一人群中很常见。可穿戴设备可以持续评估客观睡眠指标,但基于日常睡眠数据的个性化反馈仍有待探索。目的:本研究评估了多组件人工智能支持的移动健康(mHealth)干预的技术和操作可行性,该干预为高中女足球运动员提供个性化的睡眠反馈。睡眠效率是主要的初步疗效指标;其他与睡眠相关的测量是次要的或探索性的结果,情绪状态和运动损伤严重程度是探索性的结果。方法:采用随机对照试验的方法,对25名高中女子足球队队员进行随机对照试验。研究简报和系统设置于2025年8月18日开始,该试验于2026年4月7日在大学医院医学信息网络(UMIN)临床试验登记处回顾性注册(UMIN000061189)。第1至第4周为基线期。第5周基线问卷结束后,根据基线总睡眠时间(TST)中位数和匹兹堡睡眠质量指数评分对参与者进行分层,并按1:1的比例随机分为干预组(n=12)和对照组(n=13)。在第6周至第9周期间,干预组在具有有效的前一天晚上Fitbit数据的日子里通过LINE接收gpt - 40生成的个性化反馈,而对照组则每天接收非个性化的睡眠信息。技术和运营可行性结果包括消息传递成功、有效的Fitbit佩戴时间、问卷完成情况、技术问题、不良事件和隐私泄露。次要结局包括TST、睡眠后醒来(WASO)、主观睡眠质量、睡眠困难和白天嗜睡。深、浅、快速眼动(REM)睡眠持续时间、情绪状态和运动损伤严重程度是探索性结果。结果:25名受试者全部完成试验。两组的信息传递成功率和问卷完成率均为100%。干预组中位有效Fitbit佩戴夜为26 (IQR 24-28),对照组为22 (IQR 15-26)。没有发生重大技术问题、不良事件或隐私泄露。主要初步疗效指标睡眠效率的改变有利于干预组(Hodges-Lehmann组间差异为2%,95% CI 0.50%-4%; P= 0.046; r=0.35)。日本版匹兹堡睡眠质量指数(PSQI-J)总分和睡眠困难评分以及探索性结果中快速眼动睡眠持续时间和总情绪障碍的组间差异也被观察到。在TST、WASO、深睡眠或浅睡眠持续时间、白天嗜睡或运动损伤严重程度方面,组间没有观察到差异。结论:多组件人工智能支持的移动医疗干预在单团队环境下证明了技术和操作可行性。在睡眠效率和选择的主观睡眠和情绪结果方面观察到初步的、产生假设的组间差异。这些发现不应被解释为已确立有效性的证据,需要在充分有力的试验中得到证实。试验注册:UMIN临床试验注册中心UMIN000061189;https://tinyurl.com/tw3d7aku。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
JMIR Formative Research
JMIR Formative Research Medicine-Medicine (miscellaneous)
CiteScore
2.70
自引率
9.10%
发文量
579
审稿时长
12 weeks
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