The Study on the Evaluation of Acupuncture Therapy on Primary Insomnia

NCT ID: NCT05830877

Last Updated: 2024-06-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-10
• Study Completion Date: 2025-12-31

Brief Summary

Through the recruition of outpatients who clinically meet the diagnostic criteria and inclusion criteria of PI, the acupuncture group adopts Tiaoshen acupuncture, and the placebo acupuncture group adopts non-insertive acupuncture supported by the Park device, and the Pittsburgh Sleep Quality Index (PSQI) is used as the main index to evaluate the patients through the scale; subjective indicators like Chalder 14-item fatigue scale, Epworth sleepiness rating, self-rating anxiety scale (SAS), self-rating depression scale (SDS) and objective indicators like polysomnography (PSG), heart rate variability (HRV) is regarded as a secondary index, and then evaluate the clinical efficacy of Tiaoshen acupuncture on PI and explore its mechanism.

Conditions

Primary Insomnia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

the acupuncture group

the patients included in this arm will recept the Tiaoshen acupuncture.

Group Type: EXPERIMENTAL

the acupuncture group

Intervention Type: OTHER

The primary choice is to puncture GB20 with a quick puncture, which means "regulate the mind and open the way". ①Scalp acupuncture: Du 20(Baihui), EX-HN 3(Yintang), EX-HNl(Sishencong); ②Select acupoints from six acupoints for mind-regulating, ear points (both sides): heart, lung, and Shenmen; body points (both sides): LI20(Yingxiang), EXTRA 12(Anmian), ST36(Zusanli) as the main hole. ③Sleeping three needles(both sides): HT7(Shenmen), PC6(Neiguan), SP6(Sanyinjiao); ④Opening four gates: LI4(Hegu) , LR3(Taichong) ⑤Abdominal four needles:ST25(Tianshu), CV12(Zhongwan), CV4(Guanyuan). For body acupuncture, a 0.3 mm×40 mm needle was used to insert directly for 0.5-1.0 cun, and twisting to gain the qi; for auricular points, a 0.25 mm×40 mm needle was used for 2-3 minutes without manipulating the needle. The acupuncture points were retained for 30 min, and the treatment was performed once every other day, three times a week, and the curative effect was evaluated after 4 weeks of treatment.

the placebo acupuncture group

Subjects in the placebo acupuncture group will receive non-insertive acupuncture using the sham needle supported by the Park device, and the selected acupoints is the same as the acupuncture group.

Group Type: ACTIVE_COMPARATOR

the placebo acupuncture group

Intervention Type: OTHER

Subjects in the placebo acupuncture group will receive non-insertive acupuncture using the sham needle supported by the Park device. This needle has a retractable shaft and a blunt tip, they could not penetrate the skin. We gently placed the sham needle and Park device on the skin. The sham needle is then no longer manipulated to minimize any physiological effects. The selected acupoints and needle retention time were the same as for the acupuncture group. Since oblique insertion is required for acupuncture points on the head, the fixed acupuncture body of the Park device could not be used. Therefore, blunt needles are used to stimulate the head points to reduce the amount of stimulation produced by acupuncture. At the end of the treatment, the acupuncturist also used a dry cotton swab to press the acupoints so that patients could feel the withdrawal of 'real' needles.

Interventions

the acupuncture group

The primary choice is to puncture GB20 with a quick puncture, which means "regulate the mind and open the way". ①Scalp acupuncture: Du 20(Baihui), EX-HN 3(Yintang), EX-HNl(Sishencong); ②Select acupoints from six acupoints for mind-regulating, ear points (both sides): heart, lung, and Shenmen; body points (both sides): LI20(Yingxiang), EXTRA 12(Anmian), ST36(Zusanli) as the main hole. ③Sleeping three needles(both sides): HT7(Shenmen), PC6(Neiguan), SP6(Sanyinjiao); ④Opening four gates: LI4(Hegu) , LR3(Taichong) ⑤Abdominal four needles:ST25(Tianshu), CV12(Zhongwan), CV4(Guanyuan). For body acupuncture, a 0.3 mm×40 mm needle was used to insert directly for 0.5-1.0 cun, and twisting to gain the qi; for auricular points, a 0.25 mm×40 mm needle was used for 2-3 minutes without manipulating the needle. The acupuncture points were retained for 30 min, and the treatment was performed once every other day, three times a week, and the curative effect was evaluated after 4 weeks of treatment.

Intervention Type: OTHER

the placebo acupuncture group

Subjects in the placebo acupuncture group will receive non-insertive acupuncture using the sham needle supported by the Park device. This needle has a retractable shaft and a blunt tip, they could not penetrate the skin. We gently placed the sham needle and Park device on the skin. The sham needle is then no longer manipulated to minimize any physiological effects. The selected acupoints and needle retention time were the same as for the acupuncture group. Since oblique insertion is required for acupuncture points on the head, the fixed acupuncture body of the Park device could not be used. Therefore, blunt needles are used to stimulate the head points to reduce the amount of stimulation produced by acupuncture. At the end of the treatment, the acupuncturist also used a dry cotton swab to press the acupoints so that patients could feel the withdrawal of 'real' needles.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Conforming to the diagnostic criteria of traditional Chinese and Western medicine for chronic insomnia;
• Age range: 18-70 years old;
• PSQI score>7 points; SAS score > 50 or SDS score > 53;
• No communication and cognitive impairment;
• No use or withdrawal of psychoactive drugs such as anti-anxiety within one month; ·No major physical diseases;
• Those who voluntarily accept the research content and can complete various scale evaluations, polysomnography monitoring and HRV;
• Sign an informed consent form prior to the start of the study.

• Persons with a history of severe mental illness, severe head injury, and significant disturbance of consciousness;
• Those with severe liver and renal insufficiency and bleeding tendencies;
• Alcoholism (liquor ≥ 100ml/day), smoking (≥ 15 cigarettes/day), drug abuse or taking psychotropic drugs;
• People with other sleep disorders, such as sleep apnea hypopnea syndrome, paroxysmal sleeping sickness, and REM sleep behavioral disorders;
• Pregnant or nursing;
• Those with other major diseases and poor control;
• Other persons who are unwilling to sign informed consent.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Third Affiliated hospital of Zhejiang Chinese Medical University

OTHER

Sponsor Role: lead

Responsible Party

Liu Yingjun

Attending doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Third Affiliated Hospital of Zhejiang Chinese Medical University

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yingjun Liu, DR.

Role: CONTACT

frankly120@163.com

15958033054

Facility Contacts

Yingjun Liu, Doctor

Role: primary

20185003@zcmu.edu.cn

15958033054

Other Identifiers

2023ZL476

Identifier Type: -

Identifier Source: org_study_id