Chronic Insomnia
Conditions
Sponsors
Second Affiliated Hospital of Zhejiang Chinese Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Age: 18-65 years (inclusive of boundary values); Meets the diagnostic criteria for Chronic Insomnia Disorder as per the *International Classification of Sleep Disorders, 3rd Edition* (ICSD-3); Insomnia duration >3 months; Pittsburgh Sleep Quality Index (PSQI) total score >5 points; If already taking insomnia treatment medications prior to enrollment, the dosage must remain stable for at least 14 days; Capable of cooperating to complete the collection of traditional Chinese medicine (TCM) four diagnostic information and related examinations; Good compliance, voluntarily participating in this study and signing a written informed consent form.
Exclusion criteria
Exclusion criteria: Secondary insomnia caused by organic diseases (such as sleep apnea syndrome, restless legs syndrome, etc.) or other major somatic diseases; Patients with significantly abnormal liver or kidney function in laboratory tests (Child-pugh score B or C, or Meld score >18 indicates significantly abnormal liver function; acute kidney injury, acute kidney disease, or chronic kidney disease according to KDIGO guidelines indicates significantly abnormal kidney function); History of alcohol or substance abuse and dependence; Cognitive dysfunction or psychiatric abnormalities that prevent cooperation in clinical interventions and evaluations; Pregnant or breastfeeding women; Participants who have taken part in other clinical trials within the past month.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index (PSQI); | — |
Secondary
| Measure | Time frame |
|---|---|
| Insomnia Severity Index(ISI);Hyperarousal Scale(HAS);Sleep Diary;Actigraphy;Related hormones; | — |
Countries
China
Contacts
Public ContactLi Lihong
Second Affiliated Hospital of Zhejiang Chinese Medical University
Outcome results
None listed