title: Effect of acupuncture on sleep quality and hyperarousal state in patients with primary insomnia: study protocol for a randomised controlled trial.
abstract: BACKGROUND
  Primary insomnia (PI) is commonly defined as a state of having disturbed daytime activities due to poor night-time sleep quality. Studies have demonstrated that it is a disorder of 24 h hyperarousal, expressed in terms of physiological, cognitive and cortical activation. Acupuncture is considered to be beneficial to restore the normal sleep-wake cycle. The aim of the trial is to assess the therapeutic effects of acupuncture on sleep quality and hyperarousal state in patients with PI.
  
  
  METHODS
  This study is a randomised, patient-assessor-blinded, sham controlled trial. -88 eligible patients with PI will be randomised in a ratio of 1:1 to the intervention group (real acupuncture) and control group (sham acupuncture, superﬁcial insertion at irrelevant acupuncture points). Acupuncture intervention will be given to all participants three times a week for 4 weeks, followed up for 8 weeks.The primary outcome measures are the Pittsburgh Sleep Quality Index (PSQI) and Hyperarousal scale (HAS). The secondary outcomes are Fatigue scale-14 (FS-14), polysomnography (PSG), heart rate variability (HRV) and Morning Salivary Cortisol Level (MSCL). Outcomes will be evaluated at baseline, post-treatment period and 8 weeks follow-up. All main analyses will be carried out on the basis of the intention-to-treat principle.
  This protocol has been approved by the Medical Ethical Committee of Beijing Traditional Chinese Medicine Hospital (Beijing TCM Hospital) on 5 January 2015. The permission number is 2014BL-056-02. The study will present data concerning the clinical effects of treating primary insomnia with acupuncture. The results will help to demonstrate if acupuncture is an effective therapy for improving sleep quality in association with a decreased hyperarousal level as a possible underlying mechanism. The findings from this study will be shared with the healthcare professionals, general public and relevant organisations through publication of manuscripts and conference presentations.
  
  
  BACKGROUND
  ISRCTN16079489; Pre-results.
authors.affiliation: Acupuncture and Moxibustion Department, Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University, Beijing, China.
authors.forename: Jing
authors.initials: J
authors.lastname: Guo
authors.affiliation: Department of Rehabilitation Medicine, Emory University School of Medicine, Atlanta, Georgia, USA.
authors.forename: Wei
authors.initials: W
authors.lastname: Huang
authors.affiliation: Acupuncture and Moxibustion Department, Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University, Beijing, China.
authors.forename: Chu-ying
authors.initials: CY
authors.lastname: Tang
authors.affiliation: Acupuncture and Moxibustion Department, Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University, Beijing, China.
authors.forename: Gui-Ling
authors.initials: GL
authors.lastname: Wang
authors.affiliation: Acupuncture and Moxibustion Department, Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University, Beijing, China.
authors.forename: Fan
authors.initials: F
authors.lastname: Zhang
authors.affiliation: Acupuncture and Moxibustion Department, Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University, Beijing, China.
authors.forename: Lin-peng
authors.initials: LP
authors.lastname: Wang
mesh_terms: D015670:Acupuncture Therapy; D000293:Adolescent; D000328:Adult; D000368:Aged; D002681:China; D006339:Heart Rate; D006801:Humans; D006854:Hydrocortisone / Q000032:analysis; D008875:Middle Aged; D017286:Polysomnography; D012107:Research Design; D012463:Saliva / Q000737:chemistry; D012890:Sleep; D007319:Sleep Initiation and Maintenance Disorders / Q000628:therapy*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D006854:Hydrocortisone
keywords: Acupuncture; Hyperarousal state; RCT; Sleep quality; primary insomnia