The Study on the Evaluation of Acupuncture Therapy on Primary Insomnia

NCT05830877 | Recruiting

• 1 other identifier: 2023ZL476
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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

Keywords

acupuncture; Primary Insomnia; RCT

Outcome Measures

Primary Outcomes (3)

• Pittsburgh sleep quality index

  Use the PSQI score table to evaluate according to patient's situation, and analyze the score changes of the subjects' insomnia degree before and after treatment by the analysis of score data. The PSQI consists of 19 self-rated questions and 5 questions rated by sleep partners. The 19 self-assessment questions constitute 7 factors ranging from 0 to 3 points. The cumulative score of each factor component is the total score of the PSQI, and the total score ranges from 0 to 21. The higher the score, the worse the sleep quality.

  Before treatment

• Pittsburgh sleep quality index

  Use the PSQI score table to evaluate according to patient's situation, and analyze the score changes of the subjects' insomnia degree before and after treatment by the analysis of score data. The PSQI consists of 19 self-rated questions and 5 questions rated by sleep partners. The 19 self-assessment questions constitute 7 factors ranging from 0 to 3 points. The cumulative score of each factor component is the total score of the PSQI, and the total score ranges from 0 to 21. The higher the score, the worse the sleep quality.

  the 4th week of treatment

• Pittsburgh sleep quality index

  Use the PSQI score table to evaluate according to patient's situation, and analyze the score changes of the subjects' insomnia degree before and after treatment by the analysis of score data.The PSQI consists of 19 self-rated questions and 5 questions rated by sleep partners. The 19 self-assessment questions constitute 7 factors ranging from 0 to 3 points. The cumulative score of each factor component is the total score of the PSQI, and the total score ranges from 0 to 21. The higher the score, the worse the sleep quality.

  4 weeks after treatment

Secondary Outcomes (14)

• Fatigue Scale-14

  Before treatment

• Fatigue Scale-14

  the 4th week of treatment

• Fatigue Scale-14

  4 weeks after treatment

• Epworth Sleepiness Scale

  Before treatment

• Epworth Sleepiness Scale

  he 4th week of treatment

Study Arms (2)

the acupuncture group

EXPERIMENTAL

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

Other: the acupuncture group

the placebo acupuncture group

ACTIVE COMPARATOR

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.

Other: the placebo acupuncture group

Interventions

the acupuncture group 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 acupuncture group

the placebo acupuncture group 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.

the placebo acupuncture group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Third Affiliated hospital of Zhejiang Chinese Medical University: lead

Study Sites (1)

The Third Affiliated Hospital of Zhejiang Chinese Medical University

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Central Study Contacts

Yingjun Liu, DR.

CONTACT

15958033054; frankly120@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending doctor

Study Record Dates

• First Submitted: April 1, 2023
• First Posted: April 26, 2023
• Study Start: May 10, 2023
• Primary Completion: June 1, 2025
• Study Completion: December 31, 2025
• Last Updated: June 14, 2024

Record last verified: 2024-06

Locations

CN (1)