Clinical effects of acupuncture on the treatment of delayed sleep wake phase disorder (DSWPD)

Background: Delayed sleep–wake phase disorder (DSWPD) is a circadian rhythm sleep disorder. People with DSWPD fall asleep approximately 2 to 6hours later than those with normal sleep patterns, negatively affecting their ability to learn and work. According to some randomized controlled trials, acupuncture can effectively treat sleep disorders; however, no study has focused specifically on DSWPD. We verified the efficacy of acupuncture in patients with DSWPD by designing an randomized controlled trials with a sufficient sample size, and formed the basis for an improved acupuncture treatment protocol. Method/Design: This protocol describes a randomized, single-site, double-blind, sham-controlled trial in which 84 eligible participants will be enrolled and randomly distributed to either the acupuncture group (n = 42) or the sham acupuncture group (n = 42) in a 1:1 proportion. Participants will receive 20 treatment sessions over eight consecutive weeks. Sleep quality was evaluated by using the Pittsburgh Sleep Quality Index. The sleep parameters recorded will be used to measure the secondary results using actigraphy, the Morningness-Eveningness Questionnaire, Insomnia Severity Index Scale, Epworth Sleepiness Scale, Beck Depression Inventory, and Beck Anxiety Inventory. Primary outcomes and actigraphy will be evaluated at baseline, week 4, week 8, and at the first and third month after treatment. Discussion: We hypothesize that the outcomes of the proposed study will determine that acupuncture is efficient and secure for the treatment on DSWPD. Evidence for its clinical use could be provided by this positive result. Trial registration: Chinese Clinical Trial Registry, ChiCTR2000039450. Registered on October 28, 2020.