Insomnia
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) Meets the diagnostic criteria for both Western medicine and traditional Chinese medicine (TCM) syndrome identification; (2) No restrictions on gender, age 18~75 years ; (3) Pittsburgh Sleep Quality Index (PSQI) score >7 points; (4) No prior use of hypnotics, or cessation of use for more than 1 month; (5) Not participating in other clinical studies; (6) Able to clearly express personal thoughts and feelings, with no mental disorders, intellectual disabilities, etc.; (7) Fully informed about relevant matters, voluntarily participates in this trial, and signs the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Individuals with severe primary diseases of the heart, brain, liver, kidney, and hematopoietic system, as well as acute illnesses, infectious diseases, and malignant tumors; (2) Total score of the 14-item Hamilton Anxiety Scale (HAMA) =14 points; total score of the 17-item Hamilton Depression Scale (HAMD) =17 points; (3) Individuals with auricular skin damage, inflammation, or allergies to adhesive tape or alcohol; (4) Pregnant and lactating women; (5) Individuals with alcohol abuse, substance abuse, or dependence; (6) Individuals with cognitive or communication impairments.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index Scale;Insomnia Severity Index Scale;Heart-Spleen Deficiency Type Insomnia Traditional Chinese Medicine (TCM) Syndrome Scoring Scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| Hamilton Depression Rating Scale;Hamilton Anxiety Rating Scale; | — |
Countries
China
Contacts
The First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine