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
- Conditions
- insomnia
- Registration Number
- ITMCTR2000003333
- Lead Sponsor
- Anhui University of Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
(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.
(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.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Event-related Potencial P300 amplitude and latentperiod;
- Secondary Outcome Measures
Name Time Method SDS;PSQI;SAS;