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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05985512
Other study ID # ChengmeiYUAN
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 1, 2023
Est. completion date July 1, 2025

Study information

Verified date August 2023
Source Shanghai Mental Health Center
Contact Dongbin LYU
Phone 86-18516743620
Email shuiysuper@foxmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Cognitive Behavioral Therapy for Insomnia
Cognitive Behavioral Therapy for Insomnia is the main therapy for the patients. Medications include sedative-hypnotics and antidepressants with a sedative effect.

Locations

Country Name City State
China Shanghai Mental Health Center Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Shanghai Mental Health Center

Country where clinical trial is conducted

China, 

Outcome

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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