PSG Validation Study of Zensorium Biosensing Wearable Device

University of California San Diego

Status: Completed

Conditions: Healthy; Sleep Wake Disorders

Study type: Observational

Funder types: Other

Identifiers

NCT04200495

190705

Details and patient eligibility

About

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.

Full 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.

Enrollment: 68 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

68 participants in 2 patient groups

Healthy Controls

Description:

No sleep-wake disorder present

Active Sleep-Wake Disorder

Description:

Presence of Sleep-Wake Disorder