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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| head acupoints acupuncture | Experimental | Acupuncture treatment for 12 acupoints on both sides of the head |
|
| body acupoints acupuncture | Active Comparator | Acupuncture treatment for 12 acupoints on both sides of the body |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| head acupoints acupuncture | Procedure | 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. |
| 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) |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lee Tsai-Jean, MD | Contact | +886-933-750-627 | cs8336@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Lee Tsai-Jean, MD | Chang Gung Memorial Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chang Gung Memorial Hospital | Recruiting | Keelung | Taiwan |
There will be a research number representing the identity. This number will not display the name, identification number, and address.
For the results and diagnosis of the visit, the research host will maintain a confidential attitude and carefully maintain the privacy. If research results are published, the identity will remain confidential.
Please also understand that if the participant signs the consent form, the participant agrees that the visit record can be directly reviewed by the monitor, auditor, research ethics committee and the competent authority to ensure that the research process and data comply with relevant laws and regulations.
These people also promise not to violate the confidentiality of your identity.
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| body acupoints acupuncture | Procedure | The participants will undergo HT7, PC6, SP6, ST36, KI3, and LR3 body acupoints acupunture treatment 3 time/1 week for 4 weeks. |
|
| 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) |
| D001523 |
| Mental Disorders |