title: Electroacupuncture for insomnia disorder: study protocol for a randomized controlled trial.
abstract: Insomnia is a common sleep disorder that affects many adults either transiently or chronically. The societal cost of insomnia is on the rise, while long-term use of current drug treatments can involve adverse effects. Recently, electroacupuncture (EA) has been used to treat various conditions including insomnia. The objective of this study is to provide scientific evidence for the effect and safety of using EA to treat insomnia.
  
  
  
  In this multicentre, assessor-blind, three-arm, parallel-design, randomised controlled trial, 150 participants will be assigned to the EA group, the sham EA (SEA) group, or the usual care group. The EA and SEA groups will receive the specific treatments 2-3 times a week for 4 weeks, for a total of 10 sessions, whereas the usual care group will not receive EA and will continue with usual care during the same time period. The primary outcome measure will be changes in the Insomnia Severity Index 5 weeks after randomisation. The secondary outcomes will include the Pittsburgh Sleep Quality Index, the Hospital Anxiety and Depression Scale, a sleep diary, the EuroQoL-5 dimension questionnaire, the levels of melatonin and cortisol, and the Patient Global Impression of Change. Safety will be assessed at each visit.
  
  
  
  The results of this multicentre randomised controlled trial will contribute to provide rigorous clinical evidence for the effects and safety of EA for insomnia disorder.
  
  
  
  Korean Clinical Trial Registry, CRIS, KCT0001685 . Registered on 2 November 2015 (retrospectively registered). Date of enrolment of the first participant to the trial 13 October 2015.
authors.affiliation: Clinical Research Division, Korea Institute of Oriental Medicine, 1672 Yuseongdae-ro, Yuseong-gu, Daejeon, 305-811, Republic of Korea.
authors.forename: Sung-Phil
authors.initials: SP
authors.lastname: Kim
authors.affiliation: Clinical Research Division, Korea Institute of Oriental Medicine, 1672 Yuseongdae-ro, Yuseong-gu, Daejeon, 305-811, Republic of Korea. jhkim714v@gmail.com.
authors.forename: Joo-Hee
authors.initials: JH
authors.lastname: Kim
authors.affiliation: Department of Neuropsychiatry, College of Oriental Medicine, Dongeui University, 62 Yangjeong-ro, Pusanjin-gu, Pusan, Republic of Korea.
authors.forename: Bo-Kyung
authors.initials: BK
authors.lastname: Kim
authors.affiliation: Department of Oriental Gynecology, Jecheon Oriental Hospital of Semyung University, 66 Semyeong-ro, Jecheon, Republic of Korea.
authors.forename: Hyeong-Jun
authors.initials: HJ
authors.lastname: Kim
authors.affiliation: Department of Neuropsychiatry, College of Korean Medicine, Daejeon University, 176 Daedukdae-ro, Seo-gu, Daejeon, Republic of Korea.
authors.forename: In Chul
authors.initials: IC
authors.lastname: Jung
authors.affiliation: Department of Internal Medicine, College of Korean Medicine, Daejeon University, 176 Daeheung-ro, Jung-gu, Daejeon, Republic of Korea.
authors.forename: Jung Hyo
authors.initials: JH
authors.lastname: Cho
authors.affiliation: Clinical Research Division, Korea Institute of Oriental Medicine, 1672 Yuseongdae-ro, Yuseong-gu, Daejeon, 305-811, Republic of Korea.
authors.forename: Jung-Eun
authors.initials: JE
authors.lastname: Kim
authors.affiliation: Clinical Research Division, Korea Institute of Oriental Medicine, 1672 Yuseongdae-ro, Yuseong-gu, Daejeon, 305-811, Republic of Korea.
authors.forename: Mi-Kyung
authors.initials: MK
authors.lastname: Kim
authors.affiliation: Clinical Research Division, Korea Institute of Oriental Medicine, 1672 Yuseongdae-ro, Yuseong-gu, Daejeon, 305-811, Republic of Korea.
authors.forename: O-Jin
authors.initials: OJ
authors.lastname: Kwon
authors.affiliation: Clinical Research Division, Korea Institute of Oriental Medicine, 1672 Yuseongdae-ro, Yuseong-gu, Daejeon, 305-811, Republic of Korea.
authors.forename: Ae-Ran
authors.initials: AR
authors.lastname: Kim
authors.affiliation: Clinical Research Division, Korea Institute of Oriental Medicine, 1672 Yuseongdae-ro, Yuseong-gu, Daejeon, 305-811, Republic of Korea.
authors.forename: Hyo-Ju
authors.initials: HJ
authors.lastname: Park
authors.affiliation: Clinical Research Division, Korea Institute of Oriental Medicine, 1672 Yuseongdae-ro, Yuseong-gu, Daejeon, 305-811, Republic of Korea.
authors.forename: Bok-Nam
authors.initials: BN
authors.lastname: Seo
mesh_terms: D000328:Adult; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D055815:Young Adult; D015671:Electroacupuncture / Q000009:adverse effects; D006854:Hydrocortisone / Q000097:blood; D008550:Melatonin / Q000097:blood; D056910:Republic of Korea; D012107:Research Design; D012720:Severity of Illness Index; D012890:Sleep; D007319:Sleep Initiation and Maintenance Disorders / Q000097:blood / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D016032:Randomized Controlled Trials as Topic; D015337:Multicenter Studies as Topic
chemical_list: D006854:Hydrocortisone; D008550:Melatonin
keywords: Clinical research protocol; Electroacupuncture; Insomnia; Randomised controlled trial