Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Other |
App Satisfaction Survey (for WELT-IP group only) |
|
8 weeks |
|
Other |
Sleep Environment Survey |
|
8 weeks |
|
Other |
Activity data from mobile device |
Activity data is evaluated as change of number of steps from baseline to week 8. |
8 weeks |
|
Other |
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. |
8 weeks |
|
Other |
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'. |
8 weeks |
|
Primary |
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. |
8 weeks |
|
Secondary |
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. |
8 weeks |
|
Secondary |
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. |
8 weeks |
|
Secondary |
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. |
8 weeks |
|
Secondary |
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. |
8 weeks |
|
Secondary |
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. |
8 weeks |
|
Secondary |
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. |
8 weeks |
|
Secondary |
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. |
8 weeks |
|
Secondary |
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. |
8 weeks |
|
Secondary |
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. |
8 weeks |
|
Secondary |
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. |
8 weeks |
|
Secondary |
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. |
8 weeks |
|
Secondary |
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. |
14 weeks |
|
Secondary |
Percentage of subjects achieving SE = 85% |
|
8 weeks |
|
Secondary |
Compliance (completion rate of lessons, for WELT-IP group only) |
Compliance is evaluated as completion rate of lessons. |
8 weeks |
|