NCT05830877 The Study on the Evaluation of Acupuncture Therapy on Primary Insomnia
| NCT ID | NCT05830877 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Third Affiliated hospital of Zhejiang Chinese Medical University |
| Condition | Primary Insomnia |
| Study Type | INTERVENTIONAL |
| Enrollment | 84 participants |
| Start Date | 2023-05-10 |
| Primary Completion | 2025-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 84 participants in total. It began in 2023-05-10 with a primary completion date of 2025-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05830877 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Primary Insomnia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05830877 currently recruiting?
Yes, NCT05830877 is actively recruiting participants. Contact the research team at frankly120@163.com for enrollment information.
Where is the NCT05830877 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT05830877 clinical trial?
NCT05830877 is sponsored by The Third Affiliated hospital of Zhejiang Chinese Medical University. The trial plans to enroll 84 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.