InsomniaNCT05809544
Study of Efficacy of WELT-IP in Insomnia (WCTP-I-B-02)
A study testing WELT-IP in people with Insomnia, run by WELT corp at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Insomnia
- What is being tested?
- WELT-IP
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteSouth Korea
- Study dates
- 14 Oct 2022to 20 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blinded, Sham-controlled Clinical Trial to Evaluate the Safety and Efficacy of Digital Cognitive Behavioral Therapy for Insomnia
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.
Read the 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.
- Conditions
- Insomnia
- Being tested
- WELT-IP, Sham
- Keywords
- digital therapeutics
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WELT-IPDevice
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.
ShamDevice
Sham was downloaded to the subject's phone and was subject was instructed to complete sleep diary and sleep educational contents as needed.
| Study group | Role | What they receive |
|---|---|---|
| WELT-IP | Experimental | 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. Receives: Device: WELT-IP |
| Sham | Sham comparator | 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. Receives: Device: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 weeks
Secondary outcomes (11)
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.
Measured: 7 weeks
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.
Measured: 7 weeks
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.
Measured: 7 weeks
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.
Measured: 7 weeks
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.
Measured: 7 weeks
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.
Measured: 7 weeks
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.
Measured: 7 weeks
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.
Measured: 7 weeks
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.
Measured: 7 weeks
Percentage of subjects achieving SE ≥ 85%
Measured: 7 weeks
Compliance (completion rate of lessons, for WELT-IP group only)
Compliance is evaluated as completion rate of lessons.
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2023
- Study start14 Oct 2022
- Primary completion20 Feb 2023
- Study completion20 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- WELT corp
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05809544
- Sponsor's protocol ID
- WCTP-I-B-02
- Status last verified
- Mar 2023
- First submitted
- 13 Mar 2023
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee S, Park KM, Lee DH, Choi EC, Lee Y, Lee E. Impact of Adherence to Digital Cognitive Behavioral Therapy for Insomnia Effectiveness. Yonsei Med J. 2025 Oct;66(10):657-665. doi: 10.3349/ymj.2024.0398.
PubMed 40992766
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blinded, Sham-controlled Clinical Trial to Evaluate the Safety and Efficacy of Digital Cognitive Behavioral Therapy for Insomnia
- ClinicalTrials.gov ID
- NCT05809544
- Acronym / sponsor ID
- WCTP-I-B-02
- Conditions
- Insomnia
- Keywords
- digital therapeutics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- WELT corpIndustry (pharma, biotech, devices)
- Study start
- 14 Oct 2022 (actual)
- Primary completion
- 20 Feb 2023 (actual)
- Study completion
- 20 Feb 2023 (actual)
- First posted
- 12 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| WELT-IP | Experimental | Device: WELT-IPEligible 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 comparator | Device: ShamEligible 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. |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WELT-IPWELT-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. | Device | WELT-IP |
| ShamSham was downloaded to the subject's phone and was subject was instructed to complete sleep diary and sleep educational contents as needed. | Device | Sham |
Primary outcome
Change from baseline to week 7 (post-treatment) of Sleep efficiency(SE)
Time frame: 7 weeks
Sleep efficiency is calculated as percentage of Total sleep time/Time in bed.
11 secondary outcomes
Change from baseline to week 7 (post-treatment) of Sleep quality (SQ)
Time frame: 7 weeks
Change from baseline to week 7 (post-treatment) of Sleep onset latency (SOL)
Time frame: 7 weeks
Change from baseline to week 7 (post-treatment) of Wake after sleep onset (WASO)
Time frame: 7 weeks
Change from baseline to week 7 (post-treatment) of Total sleep time (TST)
Time frame: 7 weeks
Change from baseline to week 7 (post-treatment) of Number of awakening (NOA)
Time frame: 7 weeks
Change from baseline to week 7 (post-treatment) of Insomnia severity index (ISI)
Time frame: 7 weeks
Change from baseline to week 7 (post-treatment) of Dysfunctional beliefs and attitudes about sleep-16 (DBAS-16)
Time frame: 7 weeks
Change from baseline to week 7 (post-treatment) of Patient health questionnaire-9 (PHQ-9)
Time frame: 7 weeks
Change from baseline to week 7 (post-treatment) of Generalized anxiety disorder-7 item scale (GAD-7)
Time frame: 7 weeks
Percentage of subjects achieving SE ≥ 85%
Time frame: 7 weeks
Compliance (completion rate of lessons, for WELT-IP group only)
Time frame: 7 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
- Derived from this study: PubMed 40992766Lee S, Park KM, Lee DH, Choi EC, Lee Y, Lee E. Impact of Adherence to Digital Cognitive Behavioral Therapy for Insomnia Effectiveness. Yonsei Med J. 2025 Oct;66(10):657-665. doi: 10.3349/ymj.2024.0398.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WELT-IP in people with Insomnia, run by WELT corp at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline to week 7 (post-treatment) of Sleep efficiency(SE) (time frame: 7 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05809544, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2023.