Insomnia Disorder Clinical Trial
Official title:
A Research on the Typing of Insomnia Disorder Based on Multidimensional Features
Based on real world and focusing on patients with chronic sleep disorders, this study conducts a data-driven subtyping research on the clinical symptoms, polysomnography, near-infrared scanning, molecular genetics, and other characteristics of chronic insomnia disorders. It constructs a multimodal therapeutic outcome prediction model, providing a basis for personalized interventions for chronic insomnia disorder.
Status | Recruiting |
Enrollment | 216 |
Est. completion date | July 1, 2025 |
Est. primary completion date | June 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: 1. Aged between 18 and 65 years, regardless of gender; 2. Currently meeting the diagnostic criteria for insomnia disorder according to the Fifth Edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5); 3. Pittsburgh Sleep Quality Index (PSQI) total score = 10; 4. Sufficient level of education and comprehension to complete the required examinations and assessments for this study; 5. Voluntarily participating in this research and signing the informed consent form. Exclusion Criteria: 1. Currently diagnosed with other sleep disorders (sleep-related breathing disorders, periodic limb movement disorder, parasomnias, central disorders of hypersomnolence, circadian rhythm sleep-wake disorders, etc.); 2. Currently diagnosed with organic brain diseases (epilepsy, cerebrovascular disease, etc.) or other organic diseases; 3. Patients with a history of or currently diagnosed with bipolar and related disorders, obsessive-compulsive and related disorders, schizophrenia spectrum and other psychotic disorders, trauma and stressor-related disorders, dissociative disorders, or eating disorders; 4. Women who are pregnant, breastfeeding, or planning to become pregnant during the study period; 5. Insomnia caused by alcohol or substance abuse; 6. High suicide risk, with HAMD-17 suicide factor score > 2; 7. Inability to cooperate with near-infrared examinations and polysomnography due to physical conditions such as head injury, etc. |
Country | Name | City | State |
---|---|---|---|
China | Shanghai Mental Health Center | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Shanghai Mental Health Center |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | polysomnography | change in total sleep time recorded by polysomnography | the end of the eighth week | |
Primary | PSQI | change in total sleep time according to PSQI scale | the end of the 24th, 36th, 48th week |
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