A double-blind, randomized, sham-controlled study for efficacy and safety of digital therapeutics of the Sleep Index based cognitive Behavioral Therapy for Insomnia : dSIBT-I study

Not Applicable

Completed

• Conditions: Diseases of the nervous system

• Registration Number: KCT0007823
• Lead Sponsor: Asan Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2023-02-28
• Last Update Posted: 2 May 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

age from 19 to 79 adult
- having no difficulties to use smartphone application
- Insomnia Severity Index score over 15 with insomnia

Exclusion Criteria

? If you are suffering from a major mental disorder such as schizophrenia, bipolar affective disorder, or major depression
? In case of other sleep disorders such as sleep apnea or restless legs syndrome
? If you are under drug therapy (melatonin, sleeping pills, tranquilizers, antidepressants, etc.) or non-pharmacologic therapy (cognitive behavioral therapy) for insomnia within the last 3 months
? In case there is a comorbid disease that causes abnormal physical function, such as cerebrovascular disease, heart disease (heart failure, angina pectoris, myocardial infarction), severe renal or hepatic dysfunction, or lung disease
? If you are taking medications that may cause sleep disturbance
? If there is a communication problem
? If you have a physical disability that may limit your activity
? If you are pregnant or lactating

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The rate of improvement in the Insomnia severity scale (ISI) score of 6 or more or the decrease of the ISI score by less than 8 points

Secondary Outcome Measures

Name	Time	Method
ratio of subjective satisfaction scores to applications of 4 or more and significant change in the quality of life scale (WHO-5)