Actively Recruiting
The RCT Study on the Evaluation of Clinical Effect of Primary Insomnia Treated With the Tiaoshen Acupuncture
Led by The Third Affiliated hospital of Zhejiang Chinese Medical University · Updated on 2024-06-14
84
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the clinical effects of Tiaoshen acupuncture on adults with primary insomnia. This randomized, triple-blind study compares Tiaoshen acupuncture to a placebo acupuncture using a sham needle supported by the Park device. The main goal is to assess sleep quality using the Pittsburgh Sleep Quality Index (PSQI), while also exploring fatigue, sleepiness, anxiety, depression, and physiological changes measured by polysomnography and heart rate variability to understand the treatment's mechanisms. Participants are assigned to one of two groups: the acupuncture group receives Tiaoshen acupuncture involving specific acupoints on the scalp, ears, body, and abdomen with needle insertion and retention for 30 minutes, performed three times a week for four weeks. The placebo group receives non-insertive acupuncture with sham needles at the same acupoints and duration to mimic treatment without skin penetration. The study includes a treatment phase of four weeks. During the study, participants complete various assessments including PSQI, Chalder Fatigue Scale, Epworth Sleepiness Scale, Self-Rating Anxiety Scale, and Self-Rating Depression Scale before treatment, at the fourth week of treatment, and four weeks after treatment ends. Polysomnography and heart rate variability are measured at the fourth week of treatment. The study tracks these outcomes to evaluate clinical efficacy and safety over the treatment and follow-up period, with total participation lasting approximately eight weeks.
CONDITIONS
Brief Title
The Study on the Evaluation of Acupuncture Therapy on Primary Insomnia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with chronic primary insomnia by traditional Chinese and Western medicine criteria
- Aged between 18 and 70 years old
- Pittsburgh Sleep Quality Index (PSQI) score greater than 7
- Self-Rating Anxiety Scale (SAS) score above 50 or Self-Rating Depression Scale (SDS) score above 53
- No communication or cognitive impairment
- No use or withdrawal of psychoactive drugs such as anti-anxiety medications within the past month
- No major physical diseases
- Willing and able to complete scale evaluations, polysomnography monitoring, and heart rate variability tests
- Signed informed consent form before the study starts
You will not qualify if you...
- Do not meet the inclusion criteria
- History of severe mental illness, severe head injury, or significant consciousness disturbance
- Severe liver or kidney failure and bleeding disorders
- Alcohol consumption of 100ml or more per day, smoking 15 or more cigarettes per day, drug abuse, or use of psychotropic drugs
- Other sleep disorders like sleep apnea, narcolepsy, or REM sleep behavior disorder
- Pregnant or nursing women
- Other major diseases that are poorly controlled
- Unwilling to sign informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants receive either real acupuncture or placebo acupuncture treatments to evaluate their effect on primary insomnia.
3 visits per week for 4 weeks
Duration - 4 weeks
Participants are monitored for 4 weeks after treatment to assess lasting effects on sleep quality and related measures.
1 visit approximately 4 weeks after treatment
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.
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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