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).

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).
2021
Reference Module in Neuroscience and BiobehavioralPsychology
1
10
de Zambotti, Massimiliano; Menghini, Luca; Cellini, Nicola; Goldstein, Cathy; Baker, Fiona C.
File in questo prodotto:
Eventuali allegati, non sono esposti

I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.

Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11585/862791
 Attenzione

Attenzione! I dati visualizzati non sono stati sottoposti a validazione da parte dell'ateneo

Citazioni
  • ???jsp.display-item.citation.pmc??? ND
  • Scopus ND
  • ???jsp.display-item.citation.isi??? ND
social impact