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NCT04200495 · ClinicalTrials.gov registry record
PSG Validation Study of Zensorium Biosensing Wearable Device
A clinical trial of Healthy and Sleep Wake Disorders, sponsored by University of California, San Diego.
- Completed
- Registry status
- 68
- Enrollment target
- 1
- Study location
NCT04200495: Completed study of Healthy and Sleep Wake Disorders, sponsored by University of California, San Diego.
NCT04200495 is a study of Healthy and Sleep Wake Disorders that has completed, run by University of California, San Diego. The registered enrollment target is 68 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04200495, a study of Healthy and Sleep Wake Disorders, has completed, sponsored by University of California, San Diego.
- COMPLETED
- Registry status
- 68 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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)
Conditions Studied
Study Locations (1)
California
- University of California San Diego - San Diego
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 68 participants |
| Start Date | 2019-11-20 |
| Est. Completion | 2020-10-28 |
What the finished NCT04200495 record still lists
NCT04200495 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 68 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (89% lower).
The record links to 2 conditions, with Healthy appearing as the primary indexed condition, and to 0 interventions.
NCT04200495 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04200495 about?
NCT04200495 is a clinical study titled "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 Accelerom...
What is the current status of trial NCT04200495?
This trial is currently completed. The enrollment target is 68 participants. The study started on 2019-11-20. Estimated completion is 2020-10-28.
What conditions does trial NCT04200495 study?
This clinical trial studies the following conditions: Healthy, Sleep Wake Disorders.
Who is sponsoring clinical trial NCT04200495?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04200495 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04200495's enrollment target sits among peer trials
68 335th of 1090 higher than 751 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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