search
Back to results

Subtyping of Insomnia Disorders Based on Multidimensional Features

Primary Purpose

Insomnia Disorder

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy for Insomnia
Sponsored by
Shanghai Mental Health Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Insomnia Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Aged between 18 and 65 years, regardless of gender; Currently meeting the diagnostic criteria for insomnia disorder according to the Fifth Edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5); Pittsburgh Sleep Quality Index (PSQI) total score ≥ 10; Sufficient level of education and comprehension to complete the required examinations and assessments for this study; Voluntarily participating in this research and signing the informed consent form. Exclusion Criteria: 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.); Currently diagnosed with organic brain diseases (epilepsy, cerebrovascular disease, etc.) or other organic diseases; 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; Women who are pregnant, breastfeeding, or planning to become pregnant during the study period; Insomnia caused by alcohol or substance abuse; High suicide risk, with HAMD-17 suicide factor score > 2; Inability to cooperate with near-infrared examinations and polysomnography due to physical conditions such as head injury, etc.

Sites / Locations

  • Shanghai Mental Health CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Insomnia Disorder

Arm Description

Patients with insomnia disorder

Outcomes

Primary Outcome Measures

polysomnography
change in total sleep time recorded by polysomnography
PSQI
change in total sleep time according to PSQI scale

Secondary Outcome Measures

Full Information

First Posted
August 3, 2023
Last Updated
August 13, 2023
Sponsor
Shanghai Mental Health Center
search

1. Study Identification

Unique Protocol Identification Number
NCT05985512
Brief Title
Subtyping of Insomnia Disorders Based on Multidimensional Features
Official Title
A Research on the Typing of Insomnia Disorder Based on Multidimensional Features
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
June 1, 2025 (Anticipated)
Study Completion Date
July 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Mental Health Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia Disorder

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
216 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Insomnia Disorder
Arm Type
Other
Arm Description
Patients with insomnia disorder
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy for Insomnia
Other Intervention Name(s)
Pharmalogical Therapy
Intervention Description
Cognitive Behavioral Therapy for Insomnia is the main therapy for the patients. Medications include sedative-hypnotics and antidepressants with a sedative effect.
Primary Outcome Measure Information:
Title
polysomnography
Description
change in total sleep time recorded by polysomnography
Time Frame
the end of the eighth week
Title
PSQI
Description
change in total sleep time according to PSQI scale
Time Frame
the end of the 24th, 36th, 48th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged between 18 and 65 years, regardless of gender; Currently meeting the diagnostic criteria for insomnia disorder according to the Fifth Edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5); Pittsburgh Sleep Quality Index (PSQI) total score ≥ 10; Sufficient level of education and comprehension to complete the required examinations and assessments for this study; Voluntarily participating in this research and signing the informed consent form. Exclusion Criteria: 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.); Currently diagnosed with organic brain diseases (epilepsy, cerebrovascular disease, etc.) or other organic diseases; 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; Women who are pregnant, breastfeeding, or planning to become pregnant during the study period; Insomnia caused by alcohol or substance abuse; High suicide risk, with HAMD-17 suicide factor score > 2; Inability to cooperate with near-infrared examinations and polysomnography due to physical conditions such as head injury, etc.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dongbin LYU
Phone
86-18516743620
Email
shuiysuper@foxmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chengmei YUAN
Organizational Affiliation
Shanghai Mental Health Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Mental Health Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chengmei Yuan
Phone
86-13818132592
Email
yuanchengmei@yeah.net

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Subtyping of Insomnia Disorders Based on Multidimensional Features

We'll reach out to this number within 24 hrs