Subtyping of Insomnia Disorders Based on Multidimensional Features

Last updated: August 13, 2023
Sponsor: Shanghai Mental Health Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Anxiety Disorders

Treatment

Cognitive Behavioral Therapy for Insomnia

Clinical Study ID

NCT05985512
ChengmeiYUAN
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Aged between 18 and 65 years, regardless of gender;
  2. Currently meeting the diagnostic criteria for insomnia disorder according to the FifthEdition 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 examinationsand assessments for this study;
  5. Voluntarily participating in this research and signing the informed consent form.

Exclusion

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 psychoticdisorders, trauma and stressor-related disorders, dissociative disorders, or eatingdisorders;
  4. Women who are pregnant, breastfeeding, or planning to become pregnant during the studyperiod;
  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 tophysical conditions such as head injury, etc.

Study Design

Total Participants: 216
Treatment Group(s): 1
Primary Treatment: Cognitive Behavioral Therapy for Insomnia
Phase:
Study Start date:
March 01, 2023
Estimated Completion Date:
July 01, 2025

Connect with a study center

  • Shanghai Mental Health Center

    Shanghai, Shanghai 200030
    China

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.