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

Shanghai Mental Health Center1 site in 1 country216 target enrollmentMarch 1, 2023

ConditionsInsomnia Disorder

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Insomnia Disorder
Sponsor: Shanghai Mental Health Center
Enrollment: 216
Locations: 1
Primary Endpoint: polysomnography
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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, 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.

Registry

clinicaltrials.gov

Start Date

March 1, 2023

End Date

July 1, 2025

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Shanghai Mental Health Center

Responsible Party

Sponsor

Eligibility Criteria

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.