An interventional study of WELT-IP with wearable devices (Apple/galaxy watch. Oura ring) in Insomnia, sponsored by Yonsei University. Completed at 1 site in South Korea. Open to participants aged 19 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-04-01.
Sponsored by Yonsei University · Not applicable, Interventional, and Treatment
The purpose of the study was to examine safety and efficacy of cognitive behavioral therapy (CBT)-based wearable integrated digital therapeutics for insomnia patients
The investigators intend to conduct a single-arm clinical trial. Following voluntary consent during the screening visit, participants will undergo screening procedures. The screening process will proceed step by step, evaluating selection/exclusion criteria through assessments such as the Mini International Neuropsychiatric Interview (MINI), Columbia Suicide Severity Rating Scale (C-SSRS), etc. Participants who meet the selection criteria and do not meet the exclusion criteria will use the DTx app for 8 weeks. Surveys conducted after app installation (Insomnia Severity Index (ISI), Patient Health Questionnaire-9 (PHQ-9), Generalized Anxiety Disorder 7-item Scale (GAD-7), and a sleep environment questionnaire) will serve as the baseline.
During the clinical trial period, sleep diaries and compliance (lesson completion rate) (applicable only to the experimental group) will be collected through the app. Sleep diaries will be used to evaluate sleep metrics such as sleep efficiency (SE), sleep onset latency (SOL), wake after sleep onset (WASO), etc.
For the experimental group, assessments as per the protocol will be conducted at baseline (Visit 1), and safety (adverse events) evaluation and termination of app usage will occur at 9 weeks (Visit 2).
1,925 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 612 are open to participants now.
This study's enrollment of 30 is below the median of 72 across 1,689 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
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Exclusion Criteria:
Eligible subjects were able to access WELT-IP (an investigational digital therapeutic) on a mobile device (iOS and Android) as scheduled to receive cognitive behavioral therapy for insomnia (CBT-I). To collect sleep and environmental data, participants will wear the wearable devices, either (1) Apple Watch (Apple Watch Series 8 41mm (GPS)) or Galaxy Watch 5 40mm (Model: SM-R900NZAAKOO), and (2) Oura Ring (Model: Heritage), during the WELT-IP treatment period.
Device: WELT-IP with wearable devices (Apple/galaxy watch. Oura ring)
WELT-IP (an investigational digital therapeutic) is an CBT-I based intervention designed to treat insomnia, conducted in 6 sessions. It is a comprehensive program delivering sleep restriction, stimulation control, muscle relaxation, cognitive treatment, and sleep hygiene education. Main features are sleep diary, sleep reports, daily lessons of CBT-I, muscle relaxation techniques, and cognitive intervention through chatbot. By using WELT-IP simultaneously with wearing an Apple Watch/Galaxy Watch and Oura Ring, sleep and environmental data can be collected.
Change from baseline to week 9 (post-treatment) of ISI
Change from baseline to week 9 (post-treatment) of ISI. ISI has 7 questions. Total score ranges from 0 to 28, where higher scores indicate more acute symptoms of insomnia.
Time frame: 9 weeks
Secondary Outcome - Changes from baseline to week 9 of SE
Change from baseline to week 9 (post-treatment) of SE. Sleep efficiency is calculated as percentage of total sleep time/time in bed.
Time frame: 9 weeks
Changes from baseline to week 9 of SOL.
Change from baseline to week 9 (post-treatment) of SOL. Sleep onset latency is evaluated as the time it takes a person to fall asleep after going to bed.
Time frame: 9 weeks
Changes from baseline to week 9 of WASO.
Change from baseline to week 9 (post-treatment) of WASO. WASO is calculated as the total number of minutes that a person is awake after initially falling asleep.
Time frame: 9 weeks
Changes from baseline to week 9 of PHQ-9.
Change from baseline to week 9 (post-treatment) of PHQ-9. PHQ-9 has nine questions. Total score ranges from 0 to 27, where higher scores indicate more acute symptoms of depression.
Time frame: 9 weeks
Changes from baseline to week 9 of GAD-7.
Change from baseline to week 9 (post-treatment) of GAD-7. GAD-7 has seven questions. Total score ranges from 0 to 21, where higher scores indicate more acute symptoms of anxiety.
Time frame: 9 weeks
Changes from baseline to week 9 of compliance.
Compliance (completion rate or lessons) Compliance is evaluated as completion rate of lessons.
Time frame: 9 weeks
Plan to share: No
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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