Study of Efficacy of WELT-IP in Insomnia (WCTP-I-B-02)
- Conditions
- Insomnia
- Interventions
- Device: WELT-IPDevice: Sham
- Registration Number
- NCT05809544
- Lead Sponsor
- WELT corp
- 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.
- Detailed Description
This was a randomized, double-blinded, sham-controlled trial. Overall, 68 subjects were randomized into the following groups:
* WELT-IP group: WELT-IP (insomnia digital therapeutics) use
* Control group: sham app use Subjects in both groups continued to receive their clinician-directed standard-of-care treatment for insomnia, if applicable, including pharmacotherapy. After screening of sleep diary, subjects were randomized and in WELT-IP group used WELT-IP and subjects in control group used a sham for a period of 6 weeks.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 68
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description WELT-IP WELT-IP 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. Sham Sham 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.
- Primary Outcome Measures
Name Time Method Change from baseline to week 7 (post-treatment) of Sleep efficiency(SE) 7 weeks Sleep efficiency is calculated as percentage of Total sleep time/Time in bed.
- Secondary Outcome Measures
Name Time Method Change from baseline to week 7 (post-treatment) of Number of awakening (NOA) 7 weeks Number of awakening is evaluated as the number of times a person wakes up after falling asleep.
Change from baseline to week 7 (post-treatment) of Dysfunctional beliefs and attitudes about sleep-16 (DBAS-16) 7 weeks Dysfunctional beliefs and attitudes about sleep-16 has sixteen questions. Responses can range from 0 to 10, where higher scores indicate more irrational beliefs and attitudes toward sleep.
Change from baseline to week 7 (post-treatment) of Sleep quality (SQ) 7 weeks Sleep quality ranges from 1 to 5, where higher score indicates better quality of sleep.
Change from baseline to week 7 (post-treatment) of Sleep onset latency (SOL) 7 weeks Sleep onset latency is evaluated as the time it takes a person to fall asleep after going to bed.
Change from baseline to week 7 (post-treatment) of Wake after sleep onset (WASO) 7 weeks Wake after sleep onset is calculated as the total number of minutes that a person is awake after initially falling asleep.
Change from baseline to week 7 (post-treatment) of Total sleep time (TST) 7 weeks Total sleep time is calculated as the total number of minutes that a person actually sleep.
Change from baseline to week 7 (post-treatment) of Generalized anxiety disorder-7 item scale (GAD-7) 7 weeks Generalized anxiety disorder-7 item scale has seven questions. Total score ranges from 0 to 21, where higher scores indicate more acute symptoms of anxiety.
Change from baseline to week 7 (post-treatment) of Insomnia severity index (ISI) 7 weeks Insomnia severity index has seven questions. Total score ranges from 0 to 28, where higher scores indicate more acute symptoms of insomnia.
Change from baseline to week 7 (post-treatment) of Patient health questionnaire-9 (PHQ-9) 7 weeks Patient health questionnaire-9 has nine questions. Total score ranges from 0 to 27, where higher scores indicate more acute symptoms of depression.
Percentage of subjects achieving SE ≥ 85% 7 weeks Compliance (completion rate of lessons, for WELT-IP group only) 7 weeks Compliance is evaluated as completion rate of lessons.
Trial Locations
- Locations (1)
Severance Hospital
🇰🇷Seoul, Korea, Republic of