Subtyping of Insomnia Disorders Based on Multidimensional Features

Insomnia Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05985512
• Other study ID #: ChengmeiYUAN
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: July 1, 2025

Study information

• Verified date: August 2023
• Source: Shanghai Mental Health Center
• Contact: Dongbin LYU
• Phone: 86-18516743620
• Email: shuiysuper[@]foxmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 216
• Est. completion date: July 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Insomnia Disorder
• Sleep Initiation and Maintenance Disorders

Intervention

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.

Locations

Country	Name	City	State
China	Shanghai Mental Health Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Mental Health Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	polysomnography	change in total sleep time recorded by polysomnography	the end of the eighth week
Primary	PSQI	change in total sleep time according to PSQI scale	the end of the 24th, 36th, 48th week