PSG Validation Study of Zensorium Biosensing Wearable Device

Completed

Conditions studied: Sleep Wake Disorders, Healthy

In brief

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.

Key facts

Study ID

NCT04200495

Run by

University of California, San Diego

People needed

68

Starts

2019-11-20

Expected to finish

2020-10-28

Last updated by the study team

2021-02-04

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 1. Health status: Healthy, or those with sleep-wake disorders

You may not qualify if…

• Pregnancy
• Currently smoking
• Any respiratory disorder other than associated with Sleep/Wake Disorder or well-controlled asthma
• Habitual use of medications known to affect respiratory function (e.g. opioids, benzodiazepines, etc).
• Use of medication known to affect pulse pressure (Beta Blockers)
• Atrial Fibrillation
• Tattoos located on wrist

Where it is running

• University of California San Diego — San Diego, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.