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Investigate the Efficacy of 'Tongdu Wenyang' Acupuncture Intervention on Chronic Insomnia Based on Actigraphy

Phase 1
Conditions
Chronic insomnia
Registration Number
ITMCTR1900002532
Lead Sponsor
Jiangsu Provincial Hospital of Traditional Chinese Medicine
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

1. Aged 18-65 years old, meet ICSD-3 diagnostic criteria;
2. PSQI score > 5 points;
3. Signed informed consent.

Exclusion Criteria

1. Sleep disorders caused by organic diseases such as epilepsy, diabetes, cardiovascular diseases, renal failure, hypertension, metabolic diseases or benign prostatic hyperplasia;
2. Sleep disorders caused by depression, anxiety, schizophrenia or other serious mental illness;
3. Diagnosis of other sleep disorders, or any other sleep disorders found on the PSG at baseline, such as obstructive sleep apnea, rapid eye movement (REM) sleep disorder;
4. Parkinson's disease, restless legs syndrome and other abnormal physical and motor diseases
5. Acupuncture has been treated for insomnia in the past month;
6. Exclude participants who are unable to complete the scale, or those with lower education;
7. Alcohol and / or other drugs abuse or dependence.
8. received psychotropic medication;
9. With communication and cognitive impairment.

Study & Design

Study Type
Interventional study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Insomnia Severity Index;Pittsburgh Sleep Quality Index;Actigraphy;Fatigue Severity Scale;
Secondary Outcome Measures
NameTimeMethod
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