Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The investigators will conduct a single-center case series study. A total of 40 participants with insomnia will be enrolled. The aim of the study is to assess the therapeutic effect of head-point acupuncture for the treatment of insomnia.
The investigators will conduct a single-center case series study. A total of 40 participants with insomnia will be enrolled, and will undergo GV20, EX-HN-1, GV21, GV22, GV23, GV24, GV29, and bilateral GB13 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).
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lee Tsai-Jean, MD | Contact | +886-933-750-627 | cs8336@gmail.com |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |