Subtyping of Insomnia Disorders Based on Multidimensional Features

Shanghai Mental Health Center

Status: Enrolling

Conditions: Insomnia Disorder

Treatments: Behavioral: Cognitive Behavioral Therapy for Insomnia

Study type: Interventional

Funder types: Other

Identifiers

NCT05985512

ChengmeiYUAN

Details and patient eligibility

About

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.

Enrollment: 216 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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216 participants in 1 patient group

Insomnia Disorder

Other group

Description:

Patients with insomnia disorder

Treatment:

Behavioral: Cognitive Behavioral Therapy for Insomnia