Identifying different types of insomnia disorders using various patient features

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

This study is trying to figure out different types of chronic insomnia by looking at patient symptoms and other features to help create personalized treatments, including Cognitive Behavioral Therapy for Insomnia.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 216 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Shanghai Mental Health Center (Academic / other)
• Locations: 1 site (Shanghai, Shanghai)
• Trial ID: NCT05985512 on ClinicalTrials.gov

What this trial studies

This study focuses on patients with chronic insomnia disorders and employs a data-driven approach to classify these disorders based on clinical symptoms, polysomnography, near-infrared scanning, and molecular genetics. By constructing a multimodal therapeutic outcome prediction model, the study aims to provide a foundation for personalized interventions tailored to individual patient needs. The intervention involves Cognitive Behavioral Therapy for Insomnia, which is a well-established treatment method. The goal is to enhance treatment efficacy by understanding the diverse characteristics of insomnia disorders.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 65 who meet the diagnostic criteria for insomnia disorder as per DSM-5.

Not a fit: Patients with other sleep disorders or significant organic brain diseases will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more effective and personalized treatment options for patients suffering from chronic insomnia.

How similar studies have performed: While there is ongoing research in insomnia treatment, this specific approach of subtyping based on multidimensional features is relatively novel.

Eligibility criteria

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.

Where this trial is running

Shanghai, Shanghai

• Shanghai Mental Health Center — Shanghai, Shanghai, China (Recruiting)

Study contacts

• Principal investigator: Chengmei YUAN — Shanghai Mental Health Center
• Study coordinator: Dongbin LYU

Conditions Insomnia Disorder