Study of Efficacy of Digital Cognitive Behavioral Therapy With Wearable Device for Insomnia

NCT06339853 | Completed

• 1 other identifier: 1-2023-0023
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Insomnia

Outcome Measures

Primary Outcomes (1)

• 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.

  9 weeks

Secondary Outcomes (6)

• Secondary Outcome - Changes from baseline to week 9 of SE

  9 weeks

• Changes from baseline to week 9 of SOL.

  9 weeks

• Changes from baseline to week 9 of WASO.

  9 weeks

• Changes from baseline to week 9 of PHQ-9.

  9 weeks

• Changes from baseline to week 9 of GAD-7.

  9 weeks

Study Arms (1)

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 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)

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.

WELT-IP

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals aged 19 to 65 years old
• DSM-5 insomnia disorder patient
• ISI ≥11
• 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
• PHQ-9 of 20 or above
• Individuals who have actually slept less than an average of 5 hours per night over the past month
• Pregnant women or individuals planning pregnancy during the clinical trial period

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Department of Psychiatry, Severance Hospital

Seoul, 120-752, South Korea

Location

Related Publications (1)

• Moon DU, Lee Y, Lutt A, Lee S, Lee E. Adjunctive smart ring monitoring during digital cognitive behavioral therapy for insomnia. Sci Rep. 2025 Oct 30;15(1):37934. doi: 10.1038/s41598-025-24312-0.

  PMID: 41168443 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Wearable Electronic Devices

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Electrical Equipment and Supplies; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2024
• First Posted: April 1, 2024
• Study Start: September 7, 2023
• Primary Completion: February 29, 2024
• Study Completion: February 29, 2024
• Last Updated: April 1, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)