Auricular acupoint therapy for primary insomnia: a multicenter randomized controlled trial
- Conditions
- primary insomnia
- Registration Number
- ITMCTR2200006725
- Lead Sponsor
- College of Acupuncture Moxibustion and Massage, Hebei University of Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
? Meets the diagnostic criteria for the DSM-5.
?Aged 18-65 years, regardless of gender;
?The Pittsburg Sleep Quality Index(PSQI) total score was more than 7 points and the Insomnia Severity Index (ISI) score was more than 8 points but less than 21 points.
?No sedative-hypnotic drug therapy, psychotherapy, or auricular therapy were received within 2 weeks before enrollment;
?The patients were informed of the study and signed the informed consent, as well as they were willing to accept follow-up after the end of the study.
?Patients with a history of psychiatric or bipolar disorder and those with the following major sleep disorders: sleep apnea (apnea/hypopnea index > 15), restless leg syndrome, periodic limb movement during sleep (PLMS with arousal > 15 per hour), circadian rhythm disorder, and parasomnias;
?The SDS(Self-Rating Anxiety Scale) score was greater than 72 (including 72), and the SAS(Self-Rating Anxiety Scale) score was greater than 69 (including 69)
?Pregnant or lactating women;
?Ear redness, ulceration, scar and allergic to tape at the time of any therapy session;
?Patients with hemorrhagic diseases, coagulation disorders, hyperglycemia and anemia;
?The patient did not want to take the Actigraphy
?Other clinical investigators are planned to be included or have been included.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method