insomnia
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) Meet the diagnosis criterion of sub-health according to Clinical Guideline of Chinese Medicine on Sub-health and primary insomnia according to Diagnostic and statistical manual of mental disorders (DSM-?) or Chinese Classification of Mental Disorders (CCMD-3): a. Difficulty initiating or maintaining sleep for at least one month; Frequency: at least 3 nights per week; b. Significant distress or impairment on social occupational or other important functions; c. Paid excessive attention on insomnia; d. had at least one negative effects caused by insomnia; (2) Glogal score of PSQI more than 7; (3) Age between 18 and 55 (including 18 and 55 years old); (4) Provide a signed written consent form.
Exclusion criteria
Exclusion criteria: Participants were excluded if they (1) were diagnosed to with restless legs syndrome, obstructive sleep apnea syndrome, or other mental problems that cause sleep disorder (generalized anxiety disorder, panic disorder, manic or hippomanic episode, moderate or major depression); (2) had substance abuse history, such as alcohol or medications; (3) were taking herbal remedies, over-the-counter medications, or psychotropic drugs that were intended for the treatment of insomnia within the last 2 weeks prior to baseline or during the study; (4) had history of major cardiovascular diseases, liver or kidney disease, or uncontrolled endocrine disease (diabetes, hyperthyroidism et al.) (5) had participated in any clinical trial within the 3 months prior to baseline or during the study or received any acupuncture treatment during the previous 12 months prior to the baseline time point.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index, PSQI;sleep efficiency; | — |
Secondary
| Measure | Time frame |
|---|---|
| Polysomnography, PSG;Self-rating depression scale;Hamilton Anxiety Scale;SF-36; | — |
Countries
China