Clinical trial NCT04200495: PSG Validation Study of Zensorium Biosensing Wearable Device
Official title: PSG Validation Study of Zensorium Biosensing Wearable Device
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep Wake Disorders
Healthy
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: Nitto Denko Asia Technical Centre (NAT)
First posted: 2019-12-16
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy adults and those with sleep/Wake Disorders

Brief 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.

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

Primary outcomes:
measure: polysomnography derived percent REM and percent non-REM sleep
timeFrame: One overnight stay at Visit 2 (7 - 10 days following Baseline)
measure: Zensorium derived percent REM and percent Non-REM sleep
timeFrame: To be worn everyday between Baseline to visit 2 (7 -10 days)
Secondary outcomes:
measure: Sleep Diary
timeFrame: To be filled out everyday between Baseline to visit 2 (7 -10 days)
measure: Insomnia Severity Index
timeFrame: Baseline
measure: Pre-Sleep Arousal Scale
timeFrame: Baseline
measure: Berlin Questionnaire
timeFrame: Baseline
measure: Epworth Sleepiness Scale
timeFrame: Baseline
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of California San Diego
state: California
Study officials:
References: