Status:
UNKNOWN
Subtyping of Insomnia Disorders Based on Multidimensional Features
Lead Sponsor:
Shanghai Mental Health Center
Conditions:
Insomnia Disorder
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
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, molec...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2025
Estimated Enrollment :
216 Patients enrolled
Trial Details
Trial ID
NCT05985512
Start Date
March 1 2023
End Date
July 1 2025
Last Update
August 15 2023
Active Locations (1)
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1
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, China, 200030