Actively Recruiting
The Study on the Evaluation of Acupuncture Therapy on Primary Insomnia
Led by The Third Affiliated hospital of Zhejiang Chinese Medical University · Updated on 2024-06-14
84
Participants Needed
1
Research Sites
138 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
The Study on the Evaluation of Acupuncture Therapy on Primary Insomnia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Conforming to the diagnostic criteria of traditional Chinese and Western medicine for chronic insomnia
- Age between 18 and 70 years old
- Pittsburgh Sleep Quality Index (PSQI) score above 7 points
- Self-rating Anxiety Scale (SAS) score above 50 or Self-rating Depression Scale (SDS) score above 53
- No communication or cognitive impairments
- No use or withdrawal of psychoactive drugs such as anti-anxiety medications within one month
- No major physical diseases
- Willingness to accept study procedures and complete all evaluations including scale assessments, polysomnography, and heart rate variability monitoring
- Signed informed consent form prior to study start
You will not qualify if you...
- Not meeting the inclusion criteria
- History of severe mental illness, severe head injury, or significant disturbance of consciousness
- Severe liver or kidney insufficiency and bleeding tendencies
- Alcoholism (liquor 100ml or more per day), smoking 15 or more cigarettes per day, drug abuse, or use of psychotropic drugs
- Other sleep disorders such as sleep apnea hypopnea syndrome, paroxysmal sleeping sickness, or REM sleep behavior disorder
- Pregnant or nursing
- Other major diseases with poor control
- Unwilling to sign informed consent
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The Third Affiliated Hospital of Zhejiang Chinese Medical University
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
Research Team
Y
Yingjun Liu, DR.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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