CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 52 enrolled
Drug / intervention
WELT-IP +1 moredevice
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/NCT05822999
NCT05822999N/ACompleted
CompareCT.gov

A Multicenter, Randomized, Double-blinded, Sham-controlled Clinical Trial to Evaluate the Safety and Efficacy of Digital Cognitive Behavioral Therapy for Insomnia

WELT corp·interventional·Posted Apr 21, 2023·Updated Apr 21, 2023

In Brief

A clinical study evaluating WELT-IP and Sham for Insomnia. Completed, enrolled 52 participants across 1 site.

Detailed Summary

The purpose of the study was to determine safety and efficacy of WELT-IP in adult insomnia patients. WELT-IP is a cognitive behavioral therapy for insomnia (CBT-I) based digital therapeutics.

Study Details

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

Timeline

N/ACompletedFinished
20222023202420252026
First PostedApr 21, 2023
Enrollment StartDec 15, 2021
Primary CompletionApr 26, 2022
Study CompletionJun 8, 2022
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 3.2 years ago

Interventions

WELT-IPdevice

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.

Shamdevice

Sham was downloaded to the subject's phone and was subject was instructed to complete sleep diary and sleep educational contents as needed.