CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 30 enrolled
Drug / intervention
WELT-IP with wearable devices (Apple/galaxy watch. Oura ring)device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06339853
NCT06339853N/ACompleted
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A Single-arm Clinical Trial to Evaluate the Safety and Efficacy of Digital Cognitive Behavioral Therapy With Wearable Device for Insomnia

Yonsei University·interventional·Posted Apr 1, 2024·Updated Apr 1, 2024

In Brief

A clinical study evaluating WELT-IP with wearable devices (Apple/galaxy watch. Oura ring) for Insomnia. Completed, enrolled 30 participants across 1 site.

Detailed Summary

The purpose of the study was to examine safety and efficacy of cognitive behavioral therapy (CBT)-based wearable integrated digital therapeutics for insomnia patients

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInsomnia
CountriesSouth Korea
Collaborators--

Timeline

N/ACompletedFinished
202420252026
First PostedApr 1, 2024
Enrollment StartSep 7, 2023
Primary CompletionFeb 29, 2024
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 2.3 years ago

Interventions

WELT-IP with wearable devices (Apple/galaxy watch. Oura ring)device

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.