Study of Efficacy of WELT-IP in Insomnia (WCTP-I-B-02)

NCT05809544 | Completed

• 1 other identifier: WCTP-I-B-02
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Insomnia

Keywords

digital therapeutics

Outcome Measures

Primary Outcomes (1)

• Change from baseline to week 7 (post-treatment) of Sleep efficiency(SE)

  Sleep efficiency is calculated as percentage of Total sleep time/Time in bed.

  7 weeks

Secondary Outcomes (11)

• Change from baseline to week 7 (post-treatment) of Sleep quality (SQ)

  7 weeks

• Change from baseline to week 7 (post-treatment) of Sleep onset latency (SOL)

  7 weeks

• Change from baseline to week 7 (post-treatment) of Wake after sleep onset (WASO)

  7 weeks

• Change from baseline to week 7 (post-treatment) of Total sleep time (TST)

  7 weeks

• Change from baseline to week 7 (post-treatment) of Number of awakening (NOA)

  7 weeks

Other Outcomes (3)

• App Satisfaction Survey

  7 weeks

• Sleep Environment Survey

  7 weeks

• Activity data from mobile device

  7 weeks

Study Arms (2)

WELT-IP

EXPERIMENTAL

Eligible subjects were able to access WELT-IP (an investigational digital therapeutic) on a mobile device (iOS and Android) as scheduled to receive CBT-I.

Device: WELT-IP

Sham

SHAM COMPARATOR

Eligible subjects were able to access a sham app downloaded on a mobile device (iOS and Android) which included sleep diary and general content regarding sleep.

Device: Sham

Interventions

WELT-IP 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.

WELT-IP

Sham DEVICE

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

Sham

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• DSM-5 insomnia patient
• SE (sleep efficiency) \<80%
• completing screening sleep diary of 7 consecutive days
• ISI of 8 or above
• capable of using mobile device and application

You may not qualify if:

• currently on non-pharmacological treatment for insomnia (ex. CBT-I, light therapy, oriental therapy for insomnia)
• sleep disorders diagnosis other than insomnia (ex. Obstructive sleep apnea, sleep behavior problem, restless leg syndrome)
• progressive and active medical conditions
• received continuous psychotherapy such as CBT, motivational enhancement therapy, psychotherapy, and psychoanalysis in the past 3 months
• major psychiatric illness as assessed through MINI
• suicide risk as assessed through C-SSRS
• having occupational risk due to sleep restriction
• shift workers

Sponsors & Collaborators

• WELT corp: lead

Study Sites (1)

Severance Hospital

Seoul, 03722, South Korea

Location

Related Publications (1)

• Lee S, Park KM, Lee DH, Choi EC, Lee Y, Lee E. Impact of Adherence to Digital Cognitive Behavioral Therapy for Insomnia Effectiveness. Yonsei Med J. 2025 Oct;66(10):657-665. doi: 10.3349/ymj.2024.0398.

  PMID: 40992766 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double-blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a randomized, double-blinded design, with three points of measurement. The subjects will receive either the WELT-IP app or sham app.

Study Record Dates

• First Submitted: March 13, 2023
• First Posted: April 12, 2023
• Study Start: October 14, 2022
• Primary Completion: February 20, 2023
• Study Completion: February 20, 2023
• Last Updated: April 12, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)