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

WELT corp

Status: Completed

Conditions: Insomnia

Treatments: Device: WELT-IP; Device: Sham

Study type: Interventional

Funder types: Industry

Identifiers

NCT05809544

WCTP-I-B-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 68 patients

Sex: All

Ages: 19 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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68 participants in 2 patient groups

WELT-IP

Experimental group

Description:

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.

Treatment:

Device: WELT-IP

Sham

Sham Comparator group

Description:

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.

Treatment:

Device: Sham