Table 3.
Study designs of pivotal clinical trials for identified DTx products
| Product | Clinical Trial Number (Study start year) | MRCT (Single or Multiple sites) | Target Population | Randomization/Design | Blinding | Control | Sample size | Treatment period (Follow-up) | Primary endpoints |
|---|---|---|---|---|---|---|---|---|---|
| Somryst® | NCT:01438697 (2011) |
No (Single site in US) |
Patients defined by own criteria* | Randomized/Parallel-group | Single-blind (participant) | Online patient education | 303 | 9 weeks (up to 12 months) | ISI, SOL, WASO |
| Sleepio® | ISRCTN:44615689 (2011) | No (Single site in UK) | Patients diagnosed with DSM-5 | Randomized/Parallel-group | Single-blind (participant) | Online imagery relief therapy, TAU | 164 | 6 weeks (up to 14 weeks) | SE |
| Somnio® | NCT:02629913 (2016) | No (Single site in CH) | Patients diagnosed with DSM-5 | Randomized/Parallel-group | Single-blind (interviewer) | Waitlist | 56 | 6 weeks (up to 12 months) | ISI |
| SUSMED Med CBT-I® | JRCT:2032210071 (2021) | No (Multiple sites in JP) | Patients diagnosed with ICSD-3 | Randomized/Parallel-group | Double-blind | Sham app | 175 | 8 weeks (up to 10 weeks) | AIS |
| Somzz® | CRIS:KCT0007292 (2022) | No (Multiple sites in KR) | Patients diagnosed with ICSD-3 | Randomized/Parallel-group | Single-blind (participant) | Sham app | 98 | 6 weeks | ISI, SE, SOL, WASO, TST, DBAS-16, PHQ-9, GAD-7, FSS, ESS, SF-36, WPAI: SHP, EQ-5D-5L |
| WELT-I® | NCT:05809544 (2022) | No (Single site in KR) | Patients diagnosed with DSM-5 | Randomized/Parallel-group | Double-blind | Sham app | 68 | 6 weeks (up to 7 weeks) | SE |
Abbreviations: AIS: Athens Insomnia Scale; DBAS-16: Dysfunctional Beliefs and Attitudes about Sleep Scale-16; DSM-5: Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition; EQ-5D-5L: EuroQol-5D-5L; ESS: Epworth Sleepiness Scale; FSS: Fatigue Severity Scale; GAD-7: General Anxiety Disorder-7: ICSD-3: International Classification of Sleep Disorders- Third Edition; ISI: Insomnia Severity Index; PHQ-9: Patient Health Questionnaire-9; SF-36: 36-Item Short Form Survey; TAU: Treatment as usual;
* (1) required more than 30 min to fall asleep at the beginning of the night or more than 30 min of time awake after initially falling asleep for at least 3 nights per week for at least 6 months, (2) total sleep time averaged 6.5 h or less, and (3) manifested sleep disturbances (or associated daytime symptoms) causing significant distress or impairment in social, occupational, or other areas of functioning