A Comparison of the Therapeutic Effect Between Head-point Acupuncture and Conventional Body Acupuncture on Insomnia

Study Overview
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Brief Summary
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The investigators will conduct a single-center, and randomized controlled cases study. A total of 120 participants with insomnia will be enrolled. The aim of the study is to compare the therapeutic effect between head-acupoints acupuncture and body-acupoints acupuncture on Insomnia.

Detailed Description
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The investigators will conduct a single-center, and randomized controlled cases study. A total of 120 participants with insomnia will be enrolled, and randomly assigned into two groups, 60 of them are the head-acupoints acupuncture group, who will receive GV20, EX-HN-1, GV21, GV22, GV23, GV24, GV29, and bilateral GB13 head-acupoints acupuncture treatment, and 60 of them are the body-acupoints acupuncture group, who will receive bilateral HT7, PC6, SP6, ST36, KI3, LR3 body-acupoints acupuncture treatment for 4 weeks. The primary outcomes of therapeutic effect on insomnia are changes of the Pittsburgh Sleep Quality Index (PSQI), Epworth Sleepiness Scale (ESS), and the Hospital Anxiety and Depression Scale (HADS).The time frame of the three primary outcomes are: baseline week 0, week 2, week 4 and week 6. The secondary outcomes of therapeutic effect on insomnia are sleep parameters including sleep efficiency (SE), sleep awakenings (SA) and total sleep time (TST) recorded by the actigraphy (time frame: baseline week 0, week 2, week 4 and week 6), as well as the heart rate viability(HRV) recorded by the ECG monitor (time frame: baseline week 0, week1, week 2, week 3, week 4 and week 6; and 30 minutes before and 60 minutes after acupuncture through study completion).

Official Title
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A Comparison of the Therapeutic Effect Between Head-point Acupuncture and Conventional Body Acupuncture on Insomnia: A Randomized Controlled Case Study

Conditions
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Sleep Initiation and Maintenance Disorders

Intervention / Treatment
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* Procedure: head acupoints acupuncture
* Procedure: body acupoints acupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged 20 70 years, met the diagnostic criteria of insomnia according to the Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition, DSM-V) experienced insomnia at least three times a week for more than a month voluntarily agreed with the investigation and signed a written informed con- sent form before the clinical trial started. Exclusion Criteria: a pregnant or lactating woman the patient's insomnia is caused by mental disorders other than mild anxiety, the patient has serious cardiovascular, liver, kidney or hematopoietic system disease the patient's insomnia is caused by nervous system disease (eg, stroke, Parkinson's Disease) the patient has taken Chinese herbs and herbal formulas for insomnia two weeks before the trial the patient with cardiac pacemaker the patient does not want to wear portable physiological signal recording device (SOMNOwatchTM) and handheld ECG monitor the patient has a history of sleep apnea

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: head acupoints acupuncture<br>Acupuncture treatment for 12 acupoints on both sides of the head | Procedure: head acupoints acupuncture<br>* The participants will undergo GV20, EX-HN-1, GV21, GV22, GV23, GV24, GV29, and GB13 head acupoints aupunture treatment 3 times/ 1 week for 4 weeks.<br>|
| Active Comparator: body acupoints acupuncture<br>Acupuncture treatment for 12 acupoints on both sides of the body | Procedure: body acupoints acupuncture<br>* The participants will undergo HT7, PC6, SP6, ST36, KI3, and LR3 body acupoints acupunture treatment 3 time/1 week for 4 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of The Epworth sleepiness scale (ESS) | The Epworth sleepiness scale (ESS) containing eight items that ask for self-reported disclosure of the expectation of dozing in a variety of situations. A sum of responses is calculated for a total score ranging from 0 to 24, higher scores mean a worse. outcome. | Baseline week 0, week 2, week 4 & 2 weeks post-tx (week 6) | 
| Changes of The HADS(The Hospital Anxiety and Depression Scale) | The Hospital Anxiety and Depression Scale is a 14-items self-administered questionnaire, the scores ranged from 0 to 21 for anxiety and 0 to 21 for depression, higher scores mean a worse outcome. | Baseline week 0, week 2, week 4 & 2 weeks post-tx (week 6) | 
| Changes of The PSQI(Pittsburgh Sleep Quality Index) | The 19 questions are combined into seven clinically-derived component scores, each weighted equally from 0-3. The seven component scores are added to obtain a global score ranging from 0-21, with higher scores indicating worse sleep quality. | Baseline week 0, week 2, week 4 & 2 weeks post-tx (week 6) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HRV(Heart rate viability) | Frequency-domain analysis of heart rate variability (HRV), a noninvasive method, has been used to reflect cardiac autonomic nervous activity in humans. The high-frequency power (HF; 0.15-0.4 Hz) of HRV represents vagal (parasympathetic) control of heart rate. The low-frequency power (LF; 0.04- 0.15 Hz) of HRV is jointly contributed by both sympathetic and vagal nerves, whereas normalized LF (nLF) is regarded as the sympathetic modulation. | Baseline week 0, week1, week 2, week 3, week 4 and week 6; and 30 minutes before and 60 minutes after acupuncture through study completion, an average of 1 year. | 
| actigraphy (3-day) | Actigraphy provides objective estimates of sleep parameters including: SE(sleep efficiency), SA(sleep awakenings), TST(total sleep time) | Baseline week 0, week 2, week 4 & 2 weeks post-tx (week 6) | 
| sleep diary | The sleep diary provides daily subjective estimates of sleep parameters including: daytime nap, sleep aids intake, bedtime, sleep onset latency, frequency of nocturnal awakenings, awakenings duration, wake-up time, arising time, feeling upon arising (five-point scale) and sleep quality (five-point scale). | Baseline week 0, week 2, week 4 & 2 weeks post-tx (week 6) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acupuncture, primary insomnia