将理论付诸实践,通过开发一种新的数字健康技术衍生终点来改善睡眠质量
Frank Kramer1, Jonas Krauss2, Jaya Pal3
1Bayer Pharmaceuticals, Wuppertal, Germany.
Digital biomarkers
|January 26, 2026
概括
数字健康技术 (DHT) 提供了一种创新的,以患者为中心的方法来测量与更年期 (SDM) 相关的睡眠障碍. 这项研究详细介绍了新的DHT衍生睡眠终点的合作开发和验证,为改进的临床试验铺平了道路.
科学领域:
- 数字卫生技术数字卫生技术
- 绝经研究 绝经研究
- 睡眠科学 睡眠科学
背景情况:
- 与更年期 (SDM) 相关的睡眠障碍很普遍,缺乏特定的批准治疗方法.
- 目前的睡眠质量评估在方法上有所不同,这阻碍了一致的临床试验结果.
- 数字健康技术 (DHT) 为客观,以患者为中心的睡眠监测在现实环境中提供了一个有前途的途径.
研究的目的:
- 共同开发和验证一种新的数字健康技术 (DHT) 衍生的终点,用于评估更年期妇女的睡眠质量.
- 根据监管指南,证明这个新型终点的适用性.
- 将DHT衍生的终点整合到与更年期相关的治疗临床开发计划中.
主要方法:
- 一个多利益相关者合作 (药物开发商,DHT提供商,平台提供商) 形成了开发终点.
- 利用既定的框架和先前的工作,以及在一个协作平台上进行差距分析和证据整理.
- 由DHT衍生的终点 (Sleepiz One+) 在第二阶段试点研究中实施,数据与多睡眠学数据进行了验证.
主要成果:
- 新的DHT衍生终点通过对多重睡眠图的验证证明了适合目的.
- 监管反支持将DHT衍生的终点纳入elinzanetant的临床开发.
- 该DEEP堆模型为监管提交数据的结构化提供了便利.
结论:
- 由DHT衍生的睡眠终点的联合开发和验证为评估SDM提供了一种新的方法.
- 这种协作努力和生成的证据可以支持进一步的DHT开发和监管接受.
- 经过验证的终点有可能增强与更年期相关的睡眠障碍的临床试验.
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