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Recording of the event-related potentials (P300) and the effects of acupuncture at different acupoints for insomniac patients: a protocol of clinical study for a randomized controlled trial

Study on the Protective Effect and Mechanism of Acupuncture at Different Points on Myocardial Ischemia and Brain Injury Based on the Theory of

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2000003333
Enrollment
Unknown
Registered
2020-05-24
Start date
2020-06-01
Completion date
Unknown
Last updated
2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

insomnia

Interventions

Sponsors

Anhui University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Patients who meet the diagnostic criteria of modern medical insomnia; (2) Participants who meet the above-mentioned TCM diagnostic criteria for insomnia; (3) Aged 18 to 65 years old; (4) Patients with insomnia diagnosis that comply with the International Classification of Sleep Disorders (ICSD-3); (5) Participants with PSQI score> 7 points; (6) The patient has no restless leg syndrome, bidirectional affective disorder, apnea syndrome and sleep disorder related medical history; (7) Participants who voluntarily participated in the study and signed written informed consent.

Exclusion criteria

Exclusion criteria: (1) Patients with organic lesions, and do not mainly suffer from insomnia; (2) Caused by circadian rhythm sleep disorders, shift work, etc., or caused by drugs, emergency events, environmental and geographical factors, and bad habits; (3) People with severe depression, anxiety, or severe psychological trauma and mental illness; (4) Combining serious primary diseases such as cardiovascular, lung, liver, kidney and hematopoietic systems and organic diseases of the brain; (5) Women who are planning to become pregnant during pregnancy, lactation, and in the near future; (6) Patients with fear of acupuncture and moxibustion and those who cannot cooperate with the treatment.

Design outcomes

Primary

MeasureTime frame
Event-related Potencial P300 amplitude and latentperiod;

Secondary

MeasureTime frame
SDS;PSQI;SAS;

Countries

China

Contacts

Public ContactLing Hu

Anhui University of Chinese Medicine

hulingtcm@126.com+86 13956933188

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026