An interventional study of WELT-IP and Sham in Insomnia, sponsored by WELT corp. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-21.
Sponsored by WELT corp · Not applicable, Interventional, and Treatment
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.
This was a randomized, double-blinded, sham-controlled trial. Overall, 52 subjects were randomized into the following groups:
2,722 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 726 are open to participants now.
This study's enrollment of 52 is below the median of 68 across 2,350 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
Browse Sleep Initiation and Maintenance Disorders studies →WELT corp is the lead sponsor of 5 studies on the registry; 3 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: WELT-IP
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.
Device: Sham
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.
Sham was downloaded to the subject's phone and was subject was instructed to complete sleep diary and sleep educational contents as needed.
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.
Time frame: 8 weeks
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.
Time frame: 8 weeks
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.
Time frame: 8 weeks
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.
Time frame: 8 weeks
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.
Time frame: 8 weeks
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.
Time frame: 8 weeks
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.
Time frame: 8 weeks
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.
Time frame: 8 weeks
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.
Time frame: 8 weeks
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.
Time frame: 8 weeks
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.
Time frame: 8 weeks
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.
Time frame: 8 weeks
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.
Time frame: 14 weeks
Percentage of subjects achieving SE ≥ 85%
Time frame: 8 weeks
Compliance (completion rate of lessons, for WELT-IP group only)
Compliance is evaluated as completion rate of lessons.
Time frame: 8 weeks
App Satisfaction Survey (for WELT-IP group only)
Time frame: 8 weeks
Sleep Environment Survey
Time frame: 8 weeks
Activity data from mobile device
Activity data is evaluated as change of number of steps from baseline to week 8.
Time frame: 8 weeks
EuroQol 5 dimensions 5 level (EQ-5D-5L) Survey
EuroQol 5 dimensions 5 level comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.
Time frame: 8 weeks
EuroQol-visual analogue scales (EQ-VAS) Survey
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
Plan to share: No
No publications or documents are linked to this record.
Ran from Dec 2021 to primary completion in Apr 2022, 4 months.
Of 78 industry-sponsored interventional studies with no phase under Sleep Initiation and Maintenance Disorders, half reached primary completion within 6 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 23. This study's 4 months is below that.
Counting every sponsor, half of 1,285 studies reached it within 15 months; a quarter within 6 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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