NCT04200495

PSG Validation Study of Zensorium Biosensing Wearable Device

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 68 (actual)
• Sponsor: University of California, San Diego · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: —

Summary

The objective of this study is to collect data comparing the Zensorium Biosensing Wearable Device (zBWD) to polysomnography (PSG) in individuals with Sleep-Wake Disorders. zBWD is similar to other wearable devices (e.g., fitbit and apple watch) that use an optical light sensor and Tri-axis Accelerometer to record steps, activity, sleep/awake states, sleep staging, and statistical variation of pulse pressure to track stress. Specifically, it is designed to report sleep duration, non-rapid eye movement (NREM) and REM sleep duration. However, zBWD has not been validated against PSG for sleep tracking in healthy controls or in individuals with sleep-wake disorders.

Detailed description

Subjects known to have or not have sleep-wake disorder, as well as healthy subjects, will be enrolled if they otherwise meet all the inclusion criteria, and none of the exclusion criteria. Subject will be asked to complete several questionnaires and wear the zBWD for 7-days, in an off-site (Home) study, followed by a single overnight PSG study to compare the zBWD data to the current gold standard of PSG. Subjects who have completed the study will also be sent a letter thanking them for their participation and offering a summary of the results of their sleep study.

Conditions

• Sleep Wake Disorders
• Healthy

Timeline

• Start date: 2019-11-20
• Primary completion: 2020-10-28
• Completion: 2020-10-28
• First posted: 2019-12-16
• Last updated: 2021-02-04

Locations

1 site across 1 country: United States