Health TrialsbyHealthPanel

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

ConditionInsomnia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorZan Wang

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

(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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Intelligent Diagnostic and Treatment Model

    Other intervention

    Intelligent CBTI

  • Traditional treatment

    Drug

    sleep drug treatment

Treatment groups

404 Participants
are divided into 2 treatment groups
Group A: Traditional treatment groupSham comparator 1 intervention
Group B: Intelligent diagnosis and treatment groupActive comparator 1 intervention

Trial outcomes

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

Time frame
6 weeks and 3 months

Secondary outcomes

1

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

Time frame
6 weeks and 3 months
2

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

Time frame
6 weeks and 3 months
3

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

Time frame
6 weeks and 3 months
4

Change in sleep efficiency (SE) measured by sleep diary

Time frame
6 weeks and 3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zan Wang

Lead sponsor

The First Hospital of Jilin University

Sponsor institution

Source ClinicalTrials.gov
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