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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0007823
Enrollment
50
Registered
2022-10-19
Start date
2022-12-15
Completion date
Unknown
Last updated
2023-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device, Others : In the case of the test group, sleep intervention treatment was performed through the application implementing dSIBT-I, and documented information was obtained as the applicat

Sponsors

Asan Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

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

Countries

Korea, Republic of

Contacts

Public ContactSeockhoon Chung

University of Ulsan

schung@amc.seoul.kr+82-2-3010-3411

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026