Clinical Efficacy and Health Economic Evaluation of an Intelligent Diagnostic and Treatment Model

NCT07357779 | Recruiting

• 1 other identifier: CBTI-V1
• Study Type: interventional
• Target: 404
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the clinical and cost-effectiveness of an intelligent therapy based on digital cognitive behavioral therapy for insomnia disorders

Conditions

Insomnia

Outcome Measures

Primary Outcomes (1)

• the score of Insomnia Severity Index scale

  The total score ranges from 0 to 28, and a higher score indicates higher levels of insomnia severity. A score of 8 or greater is the cut point for clinically possible insomnia

  6 weeks and 3 months

Secondary Outcomes (16)

• Change in total sleep time (TST) measured by sleep diary

  6 weeks and 3 months

• Change in sleep onset latency (SOL) measured by sleep diary

  6 weeks and 3 months

• Change in wake after sleep onset (WASO) measured by sleep diary

  6 weeks and 3 months

• Change in sleep efficiency (SE) measured by sleep diary

  6 weeks and 3 months

• the value of indirect costs

  6 weeks and 3 months

Study Arms (2)

Traditional treatment group

SHAM COMPARATOR

Drug: Traditional treatment

Intelligent diagnosis and treatment group

ACTIVE COMPARATOR

Other: Intelligent Diagnostic and Treatment Model

Interventions

Intelligent Diagnostic and Treatment Model OTHER

Intelligent CBTI

Intelligent diagnosis and treatment group

Traditional treatment DRUG

sleep drug treatment

Traditional treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (1) Clinical diagnosis of insomnia disorder; (2) Cooperate to complete the questionnaire surveys.

You may not qualify if:

• (1) Current use of central nervous system stimulants; (2) Use of analgesics, theophylline preparations, steroid medications; (3) Alcohol abuse or regular alcohol intake; (4) Diagnosis of other sleep disorders (e.g., obstructive sleep apnea, rapid eye movement sleep behavior disorder, restless legs syndrome) ; (5) Sleep disorders secondary to organic diseases (e.g., epilepsy, diabetes, renal failure).

Sponsors & Collaborators

• Zan Wang: lead

Study Sites (1)

the First Hospital of Jilin University

Changchun, Jilin, 130021, China

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sleep Center Director

Study Record Dates

• First Submitted: January 4, 2026
• First Posted: January 22, 2026
• Study Start: January 20, 2026
• Primary Completion: May 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 10, 2026

Record last verified: 2026-07

Locations

CN (1)