Back to resultsStudy of Efficacy of WELT-IP in Insomnia (WCTP-I-B-01)
Primary Purpose
Insomnia
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
WELT-IP
Sham
Sponsored by
About this trial
This is an interventional treatment trial for Insomnia focused on measuring digital therapeutics
Eligibility Criteria
Inclusion Criteria: DSM-5 insomnia patient ISI of 8 or above for 7 days before baseline visit (Visit 2), completing sleep diary for more than 4 days in the guidelines 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 (before using) to week 8 (after 6 weeks of using) 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.
Secondary Outcome Measures
Change from week 1 (before using) to week 8 (after 6 weeks of using) of Sleep efficiency (SE)
Sleep efficiency is calculated as percentage of Total sleep time/time in bed.
Change from week 1 (before using) to week 8 (after 6 weeks of using) of Sleep quality (SQ)
Sleep quality ranges from 1 to 5, where higher score indicates better quality of sleep.
Change from week 1 (before using) to week 8 (after 6 weeks of using) 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 week 1 (before using) to week 8 (after 6 weeks of using) 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 week 1 (before using) to week 8 (after 6 weeks of using) of Total sleep time (TST)
Total sleep time is calculated as the total number of minutes that a person actually sleep.
Change from week 1 (before using) to week 8 (after 6 weeks of using) 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 (before using) to week 8 (after 6 weeks of using) of Pittsburgh sleep quality index (PSQI)
Pittsburgh sleep quality index has ten questions. Total score ranges from 0 to 21, where higher scores indicate lower quality of sleep.
Change from baseline (before using) to week 8 (after 6 weeks of using) 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 belief and attitude toward sleep.
Change from baseline (before using) to week 8 (after 6 weeks of using) 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 (before using) to week 8 (after 6 weeks of using) 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.
Change from baseline (before using) to week 8 (after 6 weeks of using) of Epworth sleepiness scale (ESS)
Epworth sleepiness scale has eight questions. Total score ranges from 0 to 24. A total score of 10 or less is evaluated as normal. A total score of 11 to 15 is evaluated as significant sleepiness. A total score of 16 or more is evaluated as pathological sleepiness.
Change from baseline (before using) to week 14 (after 6 weeks from close out visit) of Insomnia severity index (ISI) for WELT-IP group
Insomnia severity index has seven questions. Total score ranges from 0 to 28, where higher scores indicate more acute symptoms of insomnia.
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
1. Study Identification
Unique Protocol Identification Number
NCT05822999
Brief Title
Study of Efficacy of WELT-IP in Insomnia (WCTP-I-B-01)
Official Title
A Multicenter, 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
December 15, 2021 (Actual)
Primary Completion Date
April 26, 2022 (Actual)
Study Completion Date
June 8, 2022 (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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
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, 52 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. 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 seven points of measurement. The subjects will receive either the WELT-IP app or sham app.
Masking
ParticipantInvestigator
Masking Description
double-blinded
Allocation
Randomized
Enrollment
52 (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 (before using) to week 8 (after 6 weeks of using) 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
8 weeks
Secondary Outcome Measure Information:
Title
Change from week 1 (before using) to week 8 (after 6 weeks of using) of Sleep efficiency (SE)
Description
Sleep efficiency is calculated as percentage of Total sleep time/time in bed.
Time Frame
8 weeks
Title
Change from week 1 (before using) to week 8 (after 6 weeks of using) of Sleep quality (SQ)
Description
Sleep quality ranges from 1 to 5, where higher score indicates better quality of sleep.
Time Frame
8 weeks
Title
Change from week 1 (before using) to week 8 (after 6 weeks of using) 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
8 weeks
Title
Change from week 1 (before using) to week 8 (after 6 weeks of using) 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
8 weeks
Title
Change from week 1 (before using) to week 8 (after 6 weeks of using) of Total sleep time (TST)
Description
Total sleep time is calculated as the total number of minutes that a person actually sleep.
Time Frame
8 weeks
Title
Change from week 1 (before using) to week 8 (after 6 weeks of using) 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
8 weeks
Title
Change from baseline (before using) to week 8 (after 6 weeks of using) of Pittsburgh sleep quality index (PSQI)
Description
Pittsburgh sleep quality index has ten questions. Total score ranges from 0 to 21, where higher scores indicate lower quality of sleep.
Time Frame
8 weeks
Title
Change from baseline (before using) to week 8 (after 6 weeks of using) 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 belief and attitude toward sleep.
Time Frame
8 weeks
Title
Change from baseline (before using) to week 8 (after 6 weeks of using) 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
8 weeks
Title
Change from baseline (before using) to week 8 (after 6 weeks of using) 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
8 weeks
Title
Change from baseline (before using) to week 8 (after 6 weeks of using) of Epworth sleepiness scale (ESS)
Description
Epworth sleepiness scale has eight questions. Total score ranges from 0 to 24. A total score of 10 or less is evaluated as normal. A total score of 11 to 15 is evaluated as significant sleepiness. A total score of 16 or more is evaluated as pathological sleepiness.
Time Frame
8 weeks
Title
Change from baseline (before using) to week 14 (after 6 weeks from close out visit) of Insomnia severity index (ISI) for WELT-IP group
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
14 weeks
Title
Percentage of subjects achieving SE ≥ 85%
Time Frame
8 weeks
Title
Compliance (completion rate of lessons, for WELT-IP group only)
Description
Compliance is evaluated as completion rate of lessons.
Time Frame
8 weeks
Other Pre-specified Outcome Measures:
Title
App Satisfaction Survey (for WELT-IP group only)
Time Frame
8 weeks
Title
Sleep Environment Survey
Time Frame
8 weeks
Title
Activity data from mobile device
Description
Activity data is evaluated as change of number of steps from baseline to week 8.
Time Frame
8 weeks
Title
EuroQol 5 dimensions 5 level (EQ-5D-5L) Survey
Description
EuroQol 5 dimensions 5 level comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.
Time Frame
8 weeks
Title
EuroQol-visual analogue scales (EQ-VAS) Survey
Description
EuroQol-visual analogue scales records the self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'.
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
DSM-5 insomnia patient
ISI of 8 or above
for 7 days before baseline visit (Visit 2), completing sleep diary for more than 4 days in the guidelines
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
Facility Information:
Facility Name
Severance Hospital
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study of Efficacy of WELT-IP in Insomnia (WCTP-I-B-01)
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