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Subtyping of Insomnia Disorders Based on Multidimensional Features

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05985512
Enrollment
216
Registered
2023-08-14
Start date
2023-03-01
Completion date
2025-07-01
Last updated
2023-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia Disorder

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.

Interventions

BEHAVIORALCognitive 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.

Sponsors

Shanghai Mental Health Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
polysomnographythe end of the eighth weekchange in total sleep time recorded by polysomnography
PSQIthe end of the 24th, 36th, 48th weekchange in total sleep time according to PSQI scale

Countries

China

Contacts

Primary ContactDongbin LYU
shuiysuper@foxmail.com86-18516743620

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026