Study of Efficacy of Digital Cognitive Behavioral Therapy With Wearable Device for Insomnia
Key facts
- Who runs it
- Yonsei University
- Where
- South Korea1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 30 people enrolled
- Started
- 7 Sept 2023
- Ended
- 29 Feb 2024
- Type of study
- Interventional
- Treatments tested
- WELT-IP with wearable devices (Apple/galaxy watch. Oura ring)
- Record updated
- 1 April 2024
Who can take part
- Age
- 19 years to 65 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 15 criteriaShow less
Who can take part
- Individuals aged 19 to 65 years old
- DSM-5 insomnia disorder patient
- ISI ≥11
- Capable of using mobile device and application
Who cannot take part
- currently on non-pharmacological treatment for insomnia (ex. CBT-I, light therapy, oriental therapy for insomnia)
- received continuous psychotherapy such as CBT, motivational enhancement therapy, psychotherapy, and psychoanalysis in the past 3 months
- sleep disorders diagnosis other than insomnia (ex. Obstructive sleep apnea, sleep behavior problem, restless leg syndrome)
- progressive and active medical conditions
- 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
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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 group in the trial
- WELT-IPTreatment being tested
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.
Treatment: WELT-IP with wearable devices (Apple/galaxy watch. Oura ring)
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Single-arm Clinical Trial to Evaluate the Safety and Efficacy of Digital Cognitive Behavioral Therapy With Wearable Device for Insomnia
- Record updated
- 1 April 2024