The Study on the Evaluation of Acupuncture Therapy on Primary Insomnia

The Third Affiliated hospital of Zhejiang Chinese Medical University

Status: Enrolling

Conditions: Primary Insomnia

Treatments: Other: the placebo acupuncture group; Other: the acupuncture group

Study type: Interventional

Funder types: Other

Identifiers

NCT05830877

2023ZL476

Details and patient eligibility

About

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.

Enrollment: 84 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Exclusion criteria

• Those who do not meet the inclusion criteria;
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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84 participants in 2 patient groups

the acupuncture group

Experimental group

Description:

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

Treatment:

Other: the acupuncture group

the placebo acupuncture group

Active Comparator group

Description:

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.

Treatment:

Other: the placebo acupuncture group