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

Sleep Initiation and Maintenance Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04405427
• Other study ID #: 201900496A3
• Status: Recruiting
• Phase: N/A
• Start date: August 7, 2020
• Est. completion date: August 31, 2021

Study information

• Verified date: May 2020
• Source: Chang Gung Memorial Hospital
• Contact: Lee Tsai-Jean, MD
• Phone: +886-933-750-627
• Email: cs8336[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: August 31, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria:

1. aged 20~70 years,

2. met the diagnostic criteria of insomnia according to the Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition, DSM-V)

3. experienced insomnia at least three times a week for more than a month

4. voluntarily agreed with the investigation and signed a written informed con- sent form before the clinical trial started.

Exclusion Criteria:

1. a pregnant or lactating woman

2. the patient's insomnia is caused by mental disorders other than mild anxiety,

3. the patient has serious cardiovascular, liver, kidney or hematopoietic system disease

4. the patient's insomnia is caused by nervous system disease (eg, stroke, Parkinson's Disease)

5. the patient has taken Chinese herbs and herbal formulas for insomnia two weeks before the trial

6. the patient with cardiac pacemaker

7. the patient does not want to wear portable physiological signal recording device (SOMNOwatchTM) and handheld ECG monitor

8. the patient has a history of sleep apnea

Related Conditions & MeSH terms

• Sleep Initiation and Maintenance Disorders

Intervention

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.
• 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.

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital	Keelung

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	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.
Secondary	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)
Secondary	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)