PSG Validation Study of Zensorium Biosensing Wearable Device

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.

Study Overview

• Status: Completed
• Conditions: Sleep Wake Disorders; Healthy

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.

• Study Type: Observational
• Enrollment (Actual): 68

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92093
      • University of California San Diego

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Healthy adults and those with sleep/Wake Disorders

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Healthy Controls; No sleep-wake disorder present
Active Sleep-Wake Disorder; Presence of Sleep-Wake Disorder

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
polysomnography derived percent REM and percent non-REM sleep	A full clinical overnight polysomnography (PSG) study will be performed 7 - 10 days following visit 1. The subject will have EEG, EMG, EOG, and ECG electrodes, an adhesive body position sensor placed in standard locations. This equipment is standard for diagnostic PSG. The variables of interest from the PSG are stages of sleep as indicated by PSG including % rapid eye movement (REM; amount of time in REM sleep/Total sleep time) and % non-REM (amount of time in non-REM sleep/Total sleep time)	One overnight stay at Visit 2 (7 - 10 days following Baseline)
Zensorium derived percent REM and percent Non-REM sleep	Zensorium Biosensing Wearable Device (zBWD) will be worn for 7 to 10 days following visit 1. The variables of interest are stages of sleep as indicated by the zBWD including % rapid eye movement (REM; amount of time in REM sleep/Total sleep time) and % non-REM (amount of time in non-REM sleep/Total sleep time).	To be worn everyday between Baseline to visit 2 (7 -10 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep Diary	Tracking off-site (home) sleep for 7 to 10 days via self report diary - Sleep Efficiency, Total Sleep Time, Sleep latency, and Wake after sleep onset	To be filled out everyday between Baseline to visit 2 (7 -10 days)
Insomnia Severity Index	Insomnia Severity Index (ISI) is a widely used measure of insomnia with well-established reliability and validity. The ISI consists of seven items, three of which assess severity of insomnia (i.e., degree of difficulty falling asleep, staying asleep, and waking too early). The remaining questions tap satisfaction with sleep pattern, effect of sleep on daytime and social functioning, and concern about current sleep difficulties. Ranges from 0 (no insomnia) to 28 (Severe insomnia)	Baseline
Pre-Sleep Arousal Scale	Pre-sleep arousal scale (PSAS) is a self-administered measure in which participants rate the intensity of experienced arousal for somatic (8 items) and cognitive (8 items) subscales. The PSAS shows strong internal consistency and reliability. Higher scores indicate worse pre-sleep arousal. Ratings range from 1 (not at all) to 5 (extremely).	Baseline
Berlin Questionnaire	Berlin Questionnaire is a validated screening tool for sleep disordered breather. One question and four follow-up questions concern snoring; three questions address daytime sleepiness, with a subquestion about sleepiness behind the wheel. Lastly, the measure addresses history of high blood pressure, age, weight, height, sex, neck circumference, and ethnicity. High Risk is considered if there are 2 or more categories where the score is positive, where more categories endorsed equates to higher risk.	Baseline
Epworth Sleepiness Scale	Epworth Sleepiness Scale (ESS) is a self-administered questionnaire with 8 questions. The questions measure participants experiences of having dozed off or fallen asleep while engaged in eight different activities that differ widely in their somnificity (including sitting in traffic or watching television). can range from 0 to 24. The higher the ESS score, the higher that person's average sleep propensity in daily life (ASP), or their 'daytime sleepiness'	Baseline

Collaborators and Investigators

• Sponsor: University of California, San Diego
• Collaborators: Nitto Denko Asia Technical Centre (NAT)

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2019
• Primary Completion (Actual): October 28, 2020
• Study Completion (Actual): October 28, 2020

Study Registration Dates

• First Submitted: December 6, 2019
• First Submitted That Met QC Criteria: December 13, 2019
• First Posted (Actual): December 16, 2019

Study Record Updates

• Last Update Posted (Actual): February 4, 2021
• Last Update Submitted That Met QC Criteria: February 2, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Sleep Wake Disorders
• Other Study ID Numbers: 190705

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No