Consumer sleep technology (CST) broadly includes wearables, nearables (e.g., radio- and sonar-based smart systems, under the mattress system), and mobile stand-alone applications1 designed to be directly used by consumers. Most CST falls within the area of “wellness products”, which are not approved by the US Food & Drug Administration (FDA). This could soon change due to potential upcoming regulatory changes in digital health (e.g., “The Software Precertification (Pre-Cert) Pilot Program”, https://www.fda.gov/medical-devices/digital-health-center-excellence/digital-health-software-precertification-pre-cert-program). However, systematic use of CST as a substitute for accepted methods of sleep tracking in the diagnosis and management of sleep disorders, is currently discouraged (Khosla et al., 2018).
de Zambotti, M., Menghini, L., Cellini, N., Goldstein, C., Baker, F.C. (2021). Performance of consumer wearable sleep technology. Amsterdam : Elsevier [10.1016/B978-0-12-822963-7.00199-7].
Performance of consumer wearable sleep technology
Menghini, Luca;
2021
Abstract
Consumer sleep technology (CST) broadly includes wearables, nearables (e.g., radio- and sonar-based smart systems, under the mattress system), and mobile stand-alone applications1 designed to be directly used by consumers. Most CST falls within the area of “wellness products”, which are not approved by the US Food & Drug Administration (FDA). This could soon change due to potential upcoming regulatory changes in digital health (e.g., “The Software Precertification (Pre-Cert) Pilot Program”, https://www.fda.gov/medical-devices/digital-health-center-excellence/digital-health-software-precertification-pre-cert-program). However, systematic use of CST as a substitute for accepted methods of sleep tracking in the diagnosis and management of sleep disorders, is currently discouraged (Khosla et al., 2018).I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
