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PSG Validation Study of Zensorium Biosensing Wearable Device
NCT04200495 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04200495
The ClinicalTrials.gov registry entry for NCT04200495 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 68 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Diego, which has 823 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Healthy appearing as the primary indexed condition, and to 0 interventions. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04200495 reports 1 study location spanning 1 distinct geographic area — top geographies include California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
Who is sponsoring clinical trial NCT04200495?
This trial is sponsored by University of California, San Diego, which has 823 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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