Table 4.
DTxa clinical trial demographic data from the Digital Therapeutics Alliance Product Library—Sleepio, Somryst, and Nerivio.
| Digital Therapeutic Product | Sleepio | Somryst | Nerivio | |||||
| Company | Big Health | Pear Therapeutics | Theranica | |||||
| FDAb regulation | —c | FDA-cleared class II medical device | De novo FDA-authorized | |||||
| Study type | Randomized controlled trial | Randomized controlled trial | Prospective, randomized, double-blind, placebo-controlled, multicenter triald | |||||
| Name of study | Effect of digital cognitive behavioral therapy for insomnia on health, psychological well-being, and sleep-related quality of life: a randomized clinical trial | Effect of a web-based cognitive behavior therapy for insomnia intervention with 1-year follow-up: a randomized clinical trial | Remote electrical neuromodulation (REN) relieves acute migraine: a randomized, double-blind, placebo-controlled, multicenter trial | |||||
| Digital therapeutic clinical area of focus | Insomnia | Chronic insomnia | Migraine | |||||
| Prescription required? | No | Yes | Yes | |||||
| Demographics | ||||||||
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Sample size, n | 1711 | 303 | 252 | ||||
|
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Age (years), mean (SD) | 48.1 (13.8) | 43.3 (11.6) | 43 (12.0) | ||||
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Sex, n (%) | |||||||
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|
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Male | 382 (22.3) | 85 (28.1) | 48 (19.0) | |||
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|
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Female | 1329 (77.7) | 218 (71.9) | 204 (81.0) | |||
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Race, n (%) | |||||||
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|
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Asian | 45 (2.6) | 12 (4.0) | 0 (0) | |||
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Black | 19 (1.1) | 21 (6.9) | 0 (0) | |||
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|
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White | 1558 (91.1) | 254 (83.8) | 221 (87.7) | |||
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|
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Others | 88 (5.1) | 16 (5.3) | 31 (12.3) | |||
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Ethnicity, n (%) | |||||||
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Hispanic | — | 24 (7.9) | — | |||
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Non-Hispanic | — | 279 (92.1) | — | |||
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Education: some college or more | Mean 16.6 years of continuous educatione | n=235 (77.6%) | — | ||||
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Employment: employed at least half time, n (%) | 1152 (67.3) | 175 (57.8) | — | ||||
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Married, remarried, or partnered, n (%) | — | 181 (59.7) | — | ||||
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Percentage of participants with private insurance | — | — | — | ||||
aDTx: digital therapeutics.
bFDA: Food and Drug Administration.
cData not available in study.
dStudy reported Hispanic Ethnicity and Black or African American as one group under Race Demographic Category.
eStudy reported education as either mean years with range or median with IQR.