Back to results

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

Primary Purpose

Insomnia

Status

Completed

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

WELT-IP

Sham

About this trial

This is an interventional treatment trial for Insomnia focused on measuring digital therapeutics

Eligibility Criteria

19 Years - 65 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

Severance Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

WELT-IP

Sham

Arm 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.

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.

Outcomes

Primary Outcome Measures

Change from baseline to week 7 (post-treatment) of Sleep efficiency(SE)

Sleep efficiency is calculated as percentage of Total sleep time/Time in bed.

Secondary Outcome Measures

Change from baseline to week 7 (post-treatment) of Sleep quality (SQ)

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)

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)

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)

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 Number of awakening (NOA)

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 Insomnia severity index (ISI)

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 Dysfunctional beliefs and attitudes about sleep-16 (DBAS-16)

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 Patient health questionnaire-9 (PHQ-9)

Patient health questionnaire-9 has nine questions. Total score ranges from 0 to 27, where higher scores indicate more acute symptoms of depression.

Change from baseline to week 7 (post-treatment) of Generalized anxiety disorder-7 item scale (GAD-7)

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.

Percentage of subjects achieving SE ≥ 85%

Compliance (completion rate of lessons, for WELT-IP group only)

Compliance is evaluated as completion rate of lessons.

Full Information

NCT ID

NCT05809544

First Posted

March 13, 2023

Last Updated

April 9, 2023

Sponsor

WELT corp

1. Study Identification

Unique Protocol Identification Number

NCT05809544

Brief Title

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

Official Title

A Randomized, Double-blinded, Sham-controlled Clinical Trial to Evaluate the Safety and Efficacy of Digital Cognitive Behavioral Therapy for Insomnia

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Completed

Study Start Date

October 14, 2022 (Actual)

Primary Completion Date

February 20, 2023 (Actual)

Study Completion Date

February 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

WELT corp

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Insomnia

Keywords

digital therapeutics

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

This is a randomized, double-blinded design, with three points of measurement. The subjects will receive either the WELT-IP app or sham app.

Masking

ParticipantInvestigator

Masking Description

double-blinded

Allocation

Randomized

Enrollment

68 (Actual)

8. Arms, Groups, and Interventions

Arm Title

WELT-IP

Arm Type

Experimental

Arm 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.

Arm Title

Sham

Arm Type

Sham Comparator

Arm 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.

Intervention Type

Device

Intervention Name(s)

WELT-IP

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Sham

Intervention Description

Sham was downloaded to the subject's phone and was subject was instructed to complete sleep diary and sleep educational contents as needed.

Primary Outcome Measure Information:

Title

Change from baseline to week 7 (post-treatment) of Sleep efficiency(SE)

Description

Sleep efficiency is calculated as percentage of Total sleep time/Time in bed.

Time Frame

7 weeks

Secondary Outcome Measure Information:

Title

Change from baseline to week 7 (post-treatment) of Sleep quality (SQ)

Description

Sleep quality ranges from 1 to 5, where higher score indicates better quality of sleep.

Time Frame

7 weeks

Title

Change from baseline to week 7 (post-treatment) of Sleep onset latency (SOL)

Description

Sleep onset latency is evaluated as the time it takes a person to fall asleep after going to bed.

Time Frame

7 weeks

Title

Change from baseline to week 7 (post-treatment) of Wake after sleep onset (WASO)

Description

Wake after sleep onset is calculated as the total number of minutes that a person is awake after initially falling asleep.

Time Frame

7 weeks

Title

Change from baseline to week 7 (post-treatment) of Total sleep time (TST)

Description

Total sleep time is calculated as the total number of minutes that a person actually sleep.

Time Frame

7 weeks

Title

Change from baseline to week 7 (post-treatment) of Number of awakening (NOA)

Description

Number of awakening is evaluated as the number of times a person wakes up after falling asleep.

Time Frame

7 weeks

Title

Change from baseline to week 7 (post-treatment) of Insomnia severity index (ISI)

Description

Insomnia severity index has seven questions. Total score ranges from 0 to 28, where higher scores indicate more acute symptoms of insomnia.

Time Frame

7 weeks

Title

Change from baseline to week 7 (post-treatment) of Dysfunctional beliefs and attitudes about sleep-16 (DBAS-16)

Description

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.

Time Frame

7 weeks

Title

Change from baseline to week 7 (post-treatment) of Patient health questionnaire-9 (PHQ-9)

Description

Patient health questionnaire-9 has nine questions. Total score ranges from 0 to 27, where higher scores indicate more acute symptoms of depression.

Time Frame

7 weeks

Title

Change from baseline to week 7 (post-treatment) of Generalized anxiety disorder-7 item scale (GAD-7)

Description

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.

Time Frame

7 weeks

Title

Percentage of subjects achieving SE ≥ 85%

Time Frame

7 weeks

Title

Compliance (completion rate of lessons, for WELT-IP group only)

Description

Compliance is evaluated as completion rate of lessons.

Time Frame

7 weeks

Other Pre-specified Outcome Measures:

Title

App Satisfaction Survey

Time Frame

7 weeks

Title

Sleep Environment Survey

Time Frame

7 weeks

Title

Activity data from mobile device

Description

Activity data is evaluated as change of number of steps from baseline to week 7.

Time Frame

7 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Facility Information:

Facility Name

Severance Hospital

City

Seoul

ZIP/Postal Code

03722

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs