Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Intelligent app-based diagnosis and treatment program for insomnia

Official title: Clinical Efficacy and Health Economic Evaluation of an Intelligent Diagnostic and Treatment Model Based on Digital Cognitive Behavioral Therapy for Insomnia Disorder

Run by The First Hospital of Jilin University · NCT07357779 · Data updated 2026-11-12

This trial will try an intelligent, app-delivered cognitive behavioral therapy program to help adults with insomnia sleep better and reduce treatment costs.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment404 (estimated)
SponsorThe First Hospital of Jilin University
Academic / other
Locations1 site (Changchun, Jilin)
StatusRecruiting
StartedJanuary 20, 2026
Main results expectedMay 1, 2026
Study endsDecember 1, 2026
Registry record updatedJuly 10, 2026
Trial IDNCT07357779 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults with a clinical diagnosis of insomnia who can cooperate with completing questionnaire surveys and who do not have other primary sleep disorders or excluded medication/substance use are ideal candidates.

Probably not a fit

People with other diagnosed sleep disorders (like obstructive sleep apnea, REM behavior disorder, or restless legs), sleep problems secondary to organic disease, current alcohol abuse, or use of excluded stimulants/medications are unlikely to benefit from this program.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study compares an intelligent digital cognitive behavioral therapy for insomnia (dCBT-I) diagnostic-and-treatment model with traditional treatment at a single tertiary hospital. Adults with a clinical diagnosis of insomnia who can complete questionnaires are enrolled, while people with other primary sleep disorders, substance abuse, certain medications, or sleep problems secondary to organic disease are excluded. Participants receive either the intelligent dCBT-I pathway or usual care and complete clinical and health-economic outcome measures. The protocol focuses on both symptom improvement and cost-effectiveness of the digital approach.

Why it matters

Potential benefit: If successful, the program could expand access to personalized CBT-I, improve sleep outcomes for patients, and lower overall treatment costs.

How similar studies have gone: Multiple trials have shown that internet-based CBT-I improves insomnia symptoms, although fully integrated intelligent diagnostic-and-treatment models with formal health-economic evaluation are less widely tested.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

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

Exclusion Criteria:

* (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).

Where it's running

  • the First Hospital of Jilin University
    Changchun, Jilin, China
    Recruiting

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.