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Subtyping of Insomnia Disorders Based on Multidimensional Features

Sponsor
Shanghai Mental Health Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05985512
Collaborator
(none)
216
Enrollment
1
Location
1
Arm
28
Anticipated Duration (Months)
7.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Cognitive Behavioral Therapy for Insomnia
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
216 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
A Research on the Typing of Insomnia Disorder Based on Multidimensional Features
Actual Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Jun 1, 2025
Anticipated Study Completion Date :
Jul 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Other: Insomnia Disorder

Patients with insomnia disorder

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.
Other Names:
  • Pharmalogical Therapy

    		•

    Outcome Measures

    Primary Outcome Measures

    1. polysomnography [the end of the eighth week]

      change in total sleep time recorded by polysomnography

    2. PSQI [the end of the 24th, 36th, 48th week]

      change in total sleep time according to PSQI scale

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Shanghai Mental Health Center Shanghai Shanghai China 200030

    Sponsors and Collaborators

    • Shanghai Mental Health Center

    Investigators

    • Principal Investigator: Chengmei YUAN, Shanghai Mental Health Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Shanghai Mental Health Center
    ClinicalTrials.gov Identifier:
    NCT05985512
    Other Study ID Numbers:
    • ChengmeiYUAN
    First Posted:
    Aug 14, 2023
    Last Update Posted:
    Aug 15, 2023
    Last Verified:
    Aug 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Sleep Initiation and Maintenance Disorders

    Study Results

    No Results Posted as of Aug 15, 2023