None listed
Conditions
Interventions
Medical Device, Others : Active arm: Investigational Device is a medical device based on a software designed for the purpose of treating chronic insomnia, and the protocol of CBT-I (stimulation contro
Sponsors
Seoul National University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All the following inclusion criteria must be met to participate in this clinical trial. 1. Over 19 years old. 2. A person who is diagnosed with chronic insomnia based on the International Classification of Sleep Disorders-3 (ICSD-3). 3. over 8 points on the Insomnia Severity Index (ISI). 4. Android phone users with OS Ver.7.0 or above. 5. A person who voluntarily decided to participate in this clinical trial and signed a written informed consent form. 6. A person who is willing to comply with the protocol.
Exclusion criteria
Exclusion criteria: If any of the following exclusion criteria is met, one cannot participate in this clinical trial. 1. A person with sleep disorders other than insomnia (e.g., excessive somnolence disorder, narcolepsy, breathing related sleep disorder) 2. A person with insomnia caused by a physical disease that cannot be treated with Cognitive Behavioral Therapy for Insomnia (CBT-I) (e.g., asthma, gastroesophageal reflux) 3. A person with an underlying disorder, of which its symptoms can worsen when sleep is restricted (e.g., psychosis, bipolar disorder) 4. A person with severe depression ("Severe" according to the Hamilton Depression Rating Scale (HAMD)) 5. A person with insomnia caused by drugs (e.g., taking drugs for chronic diseases that may increase wakefulness) or caused by certain lifestyle (e.g., overdose of caffeine drinks, excessive smoking, or excessive drinking). 6. A person who must carry out a schedule that is difficult to receive sleep intervention (e.g., night workers, shift workers) 7. A person with audiovisual or cognitive impairment, who cannot receive treatment with the Investigational Device. 8. A person with difficulty using general-purpose equipment such as smartphones. 9. A person who fails to write an electronic sleep diary seven times or more within the first 10 days. 10. Pregnant or lactating woman. 11. A person who is currently participating in other clinical trials or have participated in other clinical trials within 90 days of screening date. 12. In other cases, when the investigator judges that participation in the clinical trial is inappropriate because it may affect the clinical trial results or ethically.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Insomnia Severity Index (ISI) score;Changing patterns in Sleep Efficiency (SE);Amount of change in Sleep Onset Latency (SOL) time;Amount of change in Wake After Sleep Onset (WASO) time;Amount of change in Total Sleep Time (TST);Amount of change in Dysfunctional Beliefs Attitudes About Sleep-16 (DBAS-16) Score ;Amount of change in the number of days taking somnifacient;Amount of change in Sleep Efficiency (SE) score;Amount of change in Patient Health Questionnaire-9 (PHQ-9) score;Amount of change in Generalized Anxiety Disorder-7 (GAD-7) score;Amount of change in Fatigue Severity Scale (FSS) score;Epworth Sleepiness Scale (ESS) score and amount of change in ESS score;Amount of change in Short Form health survey-36 (SF-36) score;Amount of change in Work Productivity and Activity Impairment questionnaire: Specific Health Problem (WPAI: SHP) score;Amount of change in EuroQol group 5 Dimensions 5 Levels (EQ-5D-5L) score | — |
Secondary
| Measure | Time frame |
|---|---|
| System Usability Scale (SUS) score | — |
Countries
Korea, Republic of
Contacts
Public ContactChowon Park
Seoul National University Hospital
Outcome results
None listed