NCT05985512

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
216

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 3, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

August 15, 2023

Status Verified

August 1, 2023

Enrollment Period

2.3 years

First QC Date

August 3, 2023

Last Update Submit

August 13, 2023

Conditions

Insomnia Disorder

Outcome Measures

Primary Outcomes (2)

  • polysomnography

    change in total sleep time recorded by polysomnography

    the end of the eighth week

  • PSQI

    change in total sleep time according to PSQI scale

    the end of the 24th, 36th, 48th week

Study Arms (1)

Insomnia Disorder

OTHER

Patients with insomnia disorder

Behavioral: Cognitive Behavioral Therapy for Insomnia

Interventions

Cognitive Behavioral Therapy for InsomniaBEHAVIORAL

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

Also known as: Pharmalogical Therapy
Insomnia Disorder

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Chengmei YUAN

    Shanghai Mental Health Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dongbin LYU

CONTACT

86-18516743620shuiysuper@foxmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2023

First Posted

August 14, 2023

Study Start

March 1, 2023

Primary Completion

June 1, 2025

Study Completion

July 1, 2025

Last Updated

August 15, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)