title: Effect of acupuncture on patients with insomnia: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Hypnotic drugs tend to be the dominant form of treatment of insomnia, but these come with a number of reported side effects. Acupuncture has been studied as an alternative, resulting in a rising need for methodological research towards verifying its efficacy as insomnia treatment.
  
  
  METHODS
  We describe a proposal for a single-center, patient-assessor-blinded, randomized controlled trial with two parallel arms. A total of 38 patients complete screening tests at the first visit, are registered into the clinical trial, and then randomly assigned to the experimental or sham control groups (19 patients for each group). All subjects are clinical insomnia patients who score a 6 or above on the Pittsburgh Sleep Quality Index (PSQI) and meet all inclusion criteria. All subjects are treated with acupuncture and intradermal acupuncture (IDA) three times during the first week. Five sham acupoints are used in the control group. In the experimental group, five real acupoints (PC6, SP6, HT7, KI6, and BL62) are used unilaterally in turn. Sham acupoints are over 1 cm away from each real acupoint.The primary outcomes are the scores on the Insomnia Severity Index (ISI) and PSQI. Secondary outcomes are the sleep log, the Beck Depression Inventory (BDI), the State-Trait Anxiety Inventory (STAI), the World Health Organization Quality of Life Abbreviated Version (WHOQOL-BREF), the Korean-Auditory Verbal Learning Test (K-AVLT), the Digit Span Test (DS), Event Related Potentials (ERPs) and heart rate variability (HRV) to assess emotional states, sleep quality, cognitive functioning, and electro-physiological changes.Subjects are assessed at three time points: baseline, post-treatment and follow-up. The duration of the clinical trial is 18 days.
  
  
  CONCLUSIONS
  To study the enhancement of the effectiveness of acupuncture for insomnia, we test the intradermal acupuncture method, which is performed continuously on the subject's skin and stimulated at home by the subject every night. In the trial, objective measurements including ERPs and HRV are used to evaluate states of cognition and autonomic nervous system functioning and subjective self-report questionnaires assess insomnia symptoms.'Sham' acupuncture points provided by STRICTA are used for the control group.
  
  
  BACKGROUND
  ClinicalTrials.gov: NCT01956760, registered 5 September 2013.
authors.forename: Kyung-Hun
authors.initials: KH
authors.lastname: Han
authors.forename: Sang-Young
authors.initials: SY
authors.lastname: Kim
authors.affiliation: Department of Hwabyung/Stress Clinic, Kyung Hee University Korean Medicine Hospital at Gangdong, 149, Sangil-Dong, Gangdong-gu, Seoul, Korea. lovepwr@khu.ac.kr.
authors.forename: Sun-Yong
authors.initials: SY
authors.lastname: Chung
mesh_terms: D000328:Adult; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D055815:Young Adult; D015670:Acupuncture Therapy / Q000379:methods; D001341:Autonomic Nervous System / Q000503:physiopathology; D004562:Electrocardiography; D004569:Electroencephalography; D005071:Evoked Potentials; D006339:Heart Rate; D009483:Neuropsychological Tests; D012107:Research Design; D012720:Severity of Illness Index; D012890:Sleep; D007319:Sleep Initiation and Maintenance Disorders / Q000175:diagnosis / Q000503:physiopathology / Q000523:psychology / Q000628:therapy; D013997:Time Factors; D016896:Treatment Outcome; D016032:Randomized Controlled Trials as Topic