Abstract
Background: Insomnia is very common in current society, and patients are often accompanied by a certain degree of anxiety, depression, etc. Recent studies have found that the hypothalamic-pituitary-adrenal (HPA) axis excitement-inhibition state is an important indicator of sleep quality. Wrist-ankle acupuncture (WAA) is safe and effective for insomnia. The acupressure wrist-ankle straps, based on WAA theory, is a portable WAA point compression strap, which can treat diseases by automatically applying pressure to the treatment location and be operated by patients themselves. We design this trial to evaluate the clinical effect of the acupressure wrist-ankle strap in the treatment of mild insomnia patients with anxiety disorders. Methods/design: This trial is a parallel-design, patients-assessor blinded, randomized, sham-controlled. In total, 108 patients diagnosed with mild insomnia patients with anxiety disorders will be randomly equally assigned into two groups, acupressure wrist-ankle strap group or non-acupressure wrist-ankle strap group; they will receive treatments for 8 weeks with 5 sessions each week. Rating scales, sleep monitor 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.Discussion: The results of this study will confirm the efficacy of acupressure wrist-ankle strap combined with CBTI in the treatment of mild insomnia patients with anxiety disorder and whether its mechanism is related to HPA axis. The acupressure wrist-ankle strap may become a pure physical, no side effect treatment of mild insomnia.Trial registration: Chinese Clinical Trial Registry (identifier: ChiCTR2000039352; registration date: 24 October 2020).