一系列个性化黑素补充干预治疗睡眠不良:可行性随机交叉试验个性化N-of-1治疗
Mark J Butler1,2, Thevaa Chandereng1,2, Heejoon Ahn1,2
1Northwell, 2000 Marcus Ave, Suite 300, New Hyde Park, NY, 11042-1069, United States, 1 6467667181.
JMIR formative research
|September 26, 2025
概括
使用黑激素对睡眠不良进行个性化N-of-1试验是可行的和可以接受的. 然而,黑色素并没有显著改善睡眠时间或质量,并且缺乏显著的异质性,这表明对于黑色素的使用可能不需要N-of-1试验.
科学领域:
- 睡眠医学 睡眠医学
- 药物基因组学 药物基因组学
- 数字健康数字健康
背景情况:
- 睡眠不足很普遍,并与不利的健康结果有关.
- 黑素补充剂可以改善睡眠,但治疗效果 (HTEs) 呈现出显著的异质性.
- 个性化N-of-1试验适用于评估高高温的治疗方法.
研究的目的:
- 评估个性化N-of-1试验对睡眠不良的可行性和可接受性.
- 为了确定黑激素补充剂在改善睡眠持续时间和质量的有效性.
- 评估在个体中对黑激素治疗效果的异质性.
主要方法:
- 进行了60个数字化,个性化的N-of-1交叉试验,比较黑素 (3.0毫克和0.5毫克) 与安慰剂.
- 使用了2周的基线和12周的干预期.
- 测量可用性 (系统可用性量表),满意度,睡眠时间 (Fitbit) 和睡眠质量 (共识睡眠日记).
主要成果:
- 个性化试验系统被评为可用 (SUS平均分数为76.3) 和可接受,满意度为96%.
- 对于两种黑激素剂量来说,HTE的指数都很低,这表明参与者之间存在一致的影响.
- 与安慰剂相比,黑素干预措施没有显著改善睡眠时间或睡眠质量.
结论:
- 在睡眠不足中对黑激素进行个性化N-of-1试验是可行的和可以接受的.
- 在这项研究中,补充黑素并没有显示出对睡眠时间或质量的显著益处.
- 缺乏显著的HTE表明,N-of-1试验可能不必用于未来的黑色素研究睡眠不良.
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