Subtyping of Insomnia Disorders Based on Multidimensional Features

Study Overview
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Brief Summary
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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.

Official Title
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A Research on the Typing of Insomnia Disorder Based on Multidimensional Features

Conditions
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Insomnia Disorder

Intervention / Treatment
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* Behavioral: Cognitive Behavioral Therapy for Insomnia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged between 18 and 65 years, regardless of gender; Currently meeting the diagnostic criteria for insomnia disorder according to the Fifth Edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5); Pittsburgh Sleep Quality Index (PSQI) total score ≥ 10; Sufficient level of education and comprehension to complete the required examinations and assessments for this study; Voluntarily participating in this research and signing the informed consent form. Exclusion Criteria: 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.); Currently diagnosed with organic brain diseases (epilepsy, cerebrovascular disease, etc.) or other organic diseases; 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; Women who are pregnant, breastfeeding, or planning to become pregnant during the study period; Insomnia caused by alcohol or substance abuse; High suicide risk, with HAMD-17 suicide factor score > 2; Inability to cooperate with near-infrared examinations and polysomnography due to physical conditions such as head injury, etc.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Insomnia Disorder<br>Patients with insomnia disorder | Behavioral: Cognitive Behavioral Therapy for Insomnia<br>* Cognitive Behavioral Therapy for Insomnia is the main therapy for the patients. Medications include sedative-hypnotics and antidepressants with a sedative effect.<br>* Other names: Pharmalogical Therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| polysomnography | change in total sleep time recorded by polysomnography | the end of the eighth week | 
| PSQI | change in total sleep time according to PSQI scale | the end of the 24th, 36th, 48th week |