A Comparison of the Therapeutic Effect Between Head-point Acupuncture and Conventional Body Acupuncture on Insomnia
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|ClinicalTrials.gov Identifier: NCT04405427|
Recruitment Status : Recruiting
First Posted : May 28, 2020
Last Update Posted : August 25, 2020
|Condition or disease||Intervention/treatment||Phase|
|Sleep Initiation and Maintenance Disorders||Procedure: head acupoints acupuncture Procedure: body acupoints acupuncture||Not Applicable|
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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Care Provider, Outcomes Assessor)|
|Official Title:||A Comparison of the Therapeutic Effect Between Head-point Acupuncture and Conventional Body Acupuncture on Insomnia: A Randomized Controlled Case Study|
|Actual Study Start Date :||August 7, 2020|
|Estimated Primary Completion Date :||May 31, 2021|
|Estimated Study Completion Date :||August 31, 2021|
Experimental: head acupoints acupuncture
Acupuncture treatment for 12 acupoints on both sides of the head
Procedure: head acupoints acupuncture
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.
Active Comparator: body acupoints acupuncture
Acupuncture treatment for 12 acupoints on both sides of the body
Procedure: body acupoints acupuncture
The participants will undergo HT7, PC6, SP6, ST36, KI3, and LR3 body acupoints acupunture treatment 3 time/1 week for 4 weeks.
- Changes of The Epworth sleepiness scale (ESS) [ Time Frame: Baseline week 0, week 2, week 4 & 2 weeks post-tx (week 6) ]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.
- Changes of The HADS(The Hospital Anxiety and Depression Scale) [ Time Frame: Baseline week 0, week 2, week 4 & 2 weeks post-tx (week 6) ]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.
- Changes of The PSQI(Pittsburgh Sleep Quality Index) [ Time Frame: Baseline week 0, week 2, week 4 & 2 weeks post-tx (week 6) ]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.
- HRV(Heart rate viability) [ 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, an average of 1 year. ]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.
- actigraphy (3-day) [ Time Frame: Baseline week 0, week 2, week 4 & 2 weeks post-tx (week 6) ]Actigraphy provides objective estimates of sleep parameters including: SE(sleep efficiency), SA(sleep awakenings), TST(total sleep time)
- sleep diary [ Time Frame: Baseline week 0, week 2, week 4 & 2 weeks post-tx (week 6) ]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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04405427
|Contact: Lee Tsai-Jean, MDfirstname.lastname@example.org|
|Chang Gung Memorial Hospital||Recruiting|
|Contact: Tsai-Jean LEE, MD 0978839269 Lee269@cgmh.org.tw|
|Principal Investigator:||Lee Tsai-Jean, MD||Chang Gung Memorial Hospital|