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

Launched by WELT CORP · Apr 9, 2023

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • 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