PSG Validation Study of Zensorium Biosensing Wearable Device

Launched by UNIVERSITY OF CALIFORNIA, SAN DIEGO · Dec 13, 2019

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Health status: Healthy, or those with sleep-wake disorders
• Exclusion Criteria:
• • 1. Pregnancy
• • 2. Currently smoking
• • 3. Any respiratory disorder other than associated with Sleep/Wake Disorder or well-controlled asthma
• • 4. Habitual use of medications known to affect respiratory function (e.g. opioids, benzodiazepines, etc).
• • 5. Use of medication known to affect pulse pressure (Beta Blockers)
• • 6. Atrial Fibrillation
• • 7. Tattoos located on wrist