primary insomnia
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: ? 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.
Exclusion criteria
Exclusion criteria: ?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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the response rate at week 4 after randomization; | — |
Secondary
| Measure | Time frame |
|---|---|
| sleep rate;Pittsburg Sleep Quality Index score;Self-Rating Anxiety Scale score;Self-Rating Anxiety Scale score;World Health Organization Quality of Life BREF score;Insomnia Severity Index score; | — |
Countries
China