Summary

Eligibility
for people ages 18-65 (full criteria)
Healthy Volunteers
healthy people welcome
Dates
study started
estimated completion
Principal Investigator
by Peter Colvonen
Photo of Peter Colvonen
Peter Colvonen

Description

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.

Details

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.

Keywords

Sleep Wake Disorders Healthy

Eligibility

You can join if…

Open to people ages 18-65

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

You CAN'T join if...

  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

Lead Scientist at UCSD

  • Peter Colvonen
    Dr. Colvonen received his B.A. from Wesleyan University and his Ph.D. from University of Illinois, Chicago. He completed his pre-doctoral internship at the University of California, San Diego/V.A. San Diego Healthcare System. After receiving his Ph.D., Dr. Colvonen completed a postdoctoral fellowship at UCSD focusing on PTSD treatments and Alcohol use disorder.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Diego
ID
NCT04200495
Study Type
Observational
Last Updated