Subtyping of Insomnia Disorders Based on Multidimensional Features

NCT ID: NCT05985512

Last Updated: 2023-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

216 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-01

Study Completion Date

2025-07-01

Brief Summary

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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.

Detailed Description

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Conditions

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Insomnia Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Insomnia Disorder

Patients with insomnia disorder

Group Type OTHER

Cognitive Behavioral Therapy for Insomnia

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Pharmalogical Therapy

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Mental Health Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chengmei YUAN

Role: PRINCIPAL_INVESTIGATOR

Shanghai Mental Health Center

Locations

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Shanghai Mental Health Center

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Dongbin LYU

Role: CONTACT

86-18516743620

Facility Contacts

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Chengmei Yuan

Role: primary

86-13818132592

Other Identifiers

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ChengmeiYUAN

Identifier Type: -

Identifier Source: org_study_id

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