PSG Validation Study of Zensorium Biosensing Wearable Device

NCT04200495 | Completed

• 1 other identifier: 190705
• Study Type: observational
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Wake Disorders; Healthy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Sleep Diary

  To be filled out everyday between Baseline to visit 2 (7 -10 days)

• Insomnia Severity Index

  Baseline

• Pre-Sleep Arousal Scale

  Baseline

• Berlin Questionnaire

  Baseline

• Epworth Sleepiness Scale

  Baseline

Study Arms (2)

Healthy Controls

No sleep-wake disorder present

Active Sleep-Wake Disorder

Presence of Sleep-Wake Disorder

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy adults and those with sleep/Wake Disorders

You may qualify if:

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

You may not qualify if:

• Pregnancy
• Currently smoking
• Any respiratory disorder other than associated with Sleep/Wake Disorder or well-controlled asthma
• Habitual use of medications known to affect respiratory function (e.g. opioids, benzodiazepines, etc).
• Use of medication known to affect pulse pressure (Beta Blockers)
• Atrial Fibrillation
• Tattoos located on wrist

Sponsors & Collaborators

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

Study Sites (1)

University of California San Diego

San Diego, California, 92093, United States

Location

MeSH Terms

Conditions

Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Clinical Professor

Study Record Dates

• First Submitted: December 6, 2019
• First Posted: December 16, 2019
• Study Start: November 20, 2019
• Primary Completion: October 28, 2020
• Study Completion: October 28, 2020
• Last Updated: February 4, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)