This is a randomized controlled trial to evaluate the clinical efficacy of combined electro-acupuncture and auricular acupuncture for persistent Iinsomnia in the adult population in Hong Kong.
Combined electro-acupuncture and auricular acupuncture is potential to be an alternative treatment for primary insomnia. The purpose of this study is to evaluate the clinical effectiveness of combined electroacupuncture and auricular acupuncture on persistent insomnia. This is a randomized double-blinded controlled trial. Patients will be randomly assigned to the electro-acupuncture group, the electro-acupuncture plus auricular acupuncture group or the waitlist controlled group. Patients will be put into groups and then compared.The chance of getting into each group is 3:3:1.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
224
Acupuncture at bilateral Ear Shenmen, Sishencong EX-HN1 , Anmian , Neiguan PC6 , Shenmen HT7 , Sanyinjiao SP6 , and unilateral Yintang EX-HN3 and Baihui GV20. The needles will be left for 30 min and then removed. Acupuncture treatment will consist of three sessions per week for 3 consecutive weeks. Aricular acupuncture at Ear Shenmen, Heart, Kidney, Liver, Spleen, Occiput, and Subcortex.In each treatment borneol crystals will be attached to the left or right side of the ear in alternation with adhesive plaster in each acupuncture treatment visit. Subjects will be asked to press the borneol crystals lightly for five minutes in the morning, afternoon and evening everyday and reminded them to remove the plaster and borneol crystals after 48 hours.
Acupuncture at bilateral Ear Shenmen, Sishencong EX-HN1 , Anmian , Neiguan PC6 , Shenmen HT7 , Sanyinjiao SP6 , and unilateral Yintang EX-HN3 and Baihui GV20. The needles will be left for 30 min and then removed. Acupuncture treatment will consist of three sessions per week for 3 consecutive weeks.
Queen Mary Hospital
Hong Kong, Hong Kong
Changes of sleep parameters by subjective measures using sleep log
We will measure sleep parameters (including sleep onset latency, sleep efficiency, total sleep time, times of wakening during sleep) by subjective measures using sleep log. The measure is a composite outcome measure consisting of multiple measures
Time frame: Baseline, 1-week posttreatment, 4-week posttreatment, and 13-week posttreatment
Change of self-rated sleep quality score measured by Insomnia Severity Index (ISI) questionnaire
Time frame: Baseline, 1-week posttreatment, 4-week posttreatment, and 13-week posttreatment
Change of self-rated sleep quality score measured by the Pittsburgh Sleep Quality Index (PSQI) questionnaire
Time frame: Baseline, 1-week posttreatment, 4-week posttreatment, and 13-week posttreatment
Change of anxiety and depression states measured by Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline, 1-week posttreatment, 4-week posttreatment, and 13-week posttreatment
Change of subjects' functioning regarding work/study, social life and family measured by Sheehan Disability Scale (SDS)
Time frame: Baseline, 1-week posttreatment, 4-week posttreatment, and 13-week posttreatment
Change of subjects' self-rated fatigue score measured by Multidimensional Fatigue Inventory (MFI)
Time frame: Baseline, 1-week posttreatment, 4-week posttreatment, and 13-week posttreatment
Change of subjects' likeliness of dozing measured by Epworth Sleepiness Scale (ESS)
Time frame: Baseline, 1-week posttreatment, 4-week posttreatment, and 13-week posttreatment
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Change of subjects' sleep-related cognition measured by Dysfunctional Beliefs and Attitudes about Sleep (DBAS)
Time frame: Baseline, 1-week posttreatment, 4-week posttreatment, and 13-week posttreatment
Change of subjects' sleep inhibitory behaviors measured by Sleep Hygiene Practice Scale (SHPS)
Time frame: Baseline, 1-week posttreatment, 4-week posttreatment, and 13-week posttreatment
Change of subjects' credibility to the treatment measured by Credibility of treatment rating scale
Time frame: Second and the last time of the treatment; 1-week posttreatment, 4-week posttreatment, and 13-week posttreatment
Change of sleep parameters (sleep onset latency, sleep efficiency, total sleep time, times of wakening during sleep) by objective measure - wrist actigraphy
Sleep parameters include sleep onset latency, sleep efficiency, total sleep time, times of wakening during sleep. The measure is a composite outcome measure consisting of multiple measures
Time frame: Baseline, 1-week posttreatment, 4-week posttreatment, and 13-week posttreatment
Change of serious adverse events measured by Serious Adverse Event (SAE)
Time frame: 1-week posttreatment, 4-week posttreatment, and 13-week posttreatment
Change of potential adverse events related to acupuncture measured by Adverse Events Report Related to Acupuncture
Time frame: 1-week posttreatment, 4-week posttreatment, and 13-week posttreatment