Evaluating acupuncture for treating primary insomnia
The RCT Study on the Evaluation of Clinical Effect of Primary Insomnia Treated With the Tiaoshen Acupuncture
This study is testing whether Tiaoshen acupuncture can help people with primary insomnia sleep better compared to a fake acupuncture treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | The Third Affiliated hospital of Zhejiang Chinese Medical University Academic / other |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT05830877 on ClinicalTrials.gov |
What this trial studies
This study recruits outpatients diagnosed with primary insomnia to evaluate the efficacy of Tiaoshen acupuncture compared to a placebo acupuncture treatment. Participants will undergo assessments using the Pittsburgh Sleep Quality Index and other subjective and objective measures, including polysomnography and heart rate variability. The goal is to determine the clinical effectiveness of acupuncture in improving sleep quality and to explore its underlying mechanisms.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-70 who meet the diagnostic criteria for chronic insomnia and have a Pittsburgh Sleep Quality Index score greater than 7.
Not a fit: Patients with severe mental illnesses, significant cognitive impairments, or other sleep disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a non-pharmacological treatment option for patients suffering from primary insomnia.
How similar studies have performed: Previous studies have shown promising results for acupuncture in treating insomnia, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Hangzhou, Zhejiang
- The Third Affiliated Hospital of Zhejiang Chinese Medical University — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Study coordinator: Yingjun Liu, DR.
- Email: frankly120@163.com
- Phone: 15958033054
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.