METHODS: This trial is a parallel-design, patients-assessor blinded, randomized, sham-controlled. In total, 114 patients diagnosed with mild insomnia and anxiety disorders will be randomly assigned into two groups, the acupressure wrist-ankle strap group or the non-acupressure wrist-ankle strap group; they will receive treatments for eight weeks with five sessions each week. Rating scales, sleep monitors, and laboratory tests will be used to observe the clinical effect. From the perspective of the circadian secretion of peripheral blood-related hormones in the hypothalamic-pituitary-adrenal (HPA) axis, the possible mechanism of acupressure wrist-ankle straps for treating insomnia is studied.
CONCLUSIONS: The results of this study will confirm the efficacy of acupressure wrist-ankle strap in treating mild insomnia patients with anxiety disorder and whether its mechanism is related to the HPA axis. The acupressure wrist-ankle strap may become a pure physical, no side effect treatment of mild insomnia.
BACKGROUND: Chinese Clinical Trial Registry ChiCTR2000039352 . Registered on 24 October 2020.
方法:该试验是并行设计,患者-评估者失明,随机化,假控制。总的来说,114名诊断为轻度失眠和焦虑症的患者将被随机分为两组,指压腕踝带组或非指压腕踝带组;他们将接受为期八周的治疗,每周五次。评级量表,睡眠监视器,和实验室检查将用于观察临床效果。从下丘脑-垂体-肾上腺(HPA)轴的外周血相关激素的昼夜节律分泌的角度来看,研究了指压腕踝带治疗失眠的可能机制。
结论:本研究结果将证实指压腕踝带治疗轻度失眠伴焦虑症患者的疗效及其机制是否与HPA轴有关。指压腕踝带可能成为一个纯粹的物理,治疗轻度失眠无副作用。
背景:中国临床试验注册ChiCTR2000039352。于2020年10月24日注册。