Lead Sponsor

Qilu Hospital of Shandong University

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Yes

•Meet the diagnostic criteria for insomnia disorder.
•Be between 18 and 80 years of age, inclusive.
•Have questionnaire scores indicating clinical significance:
•Pittsburgh Sleep Quality Index (PSQI) score \> 5 Insomnia Severity Index (ISI) score \> 7 Hamilton Anxiety Scale (HAMA) score \> 7 and/or Hamilton Depression Scale (HAMD) score ≥ 7
•Be able to communicate effectively and provide informed consent in the primary language of the study site.
•Provide written informed consent prior to participation

•Insomnia that is secondary to another underlying physical or medical condition.
•A primary diagnosis of another sleep disorder (e.g., sleep apnea, restless legs syndrome) or a primary mood disorder that is considered the main cause of sleep disturbance.
•Chronic sleep disturbances primarily attributable to environmental or lifestyle factors (e.g., shift work, excessive noise, childcare duties).