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Real-time State of Vigilance Monitor for the Neonatal Intensive Care Unit
NCT04920175 · View on ClinicalTrials.gov ↗
Study Summary
The goal of this observational study is to collect data to develop a complete package (hardware, user interface software and algorithms) that can monitor sleep-wake stages in neonates. Real-time EEG data will be used to develop and refine the prototype monitor's ability to provide direct real-time information about sleep-wake state. The study design includes multiple iterative training/testing stages to refine the prototype. The study is divided into multiple sub-aims conducted in parallel: data acquisition, algorithm development (including comparison between gold-standard polysomnogram vs. novel algorithm markings of sleep-stages), and graphical user interface software development. The data acquisition and algorithm development are iterative and linked, such that the prototype algorithm from one iteration will be deployed real-time during the next iteration of data acquisition. This allows verification that the algorithm can perform real-time and provides prospective testing data, which is later folded into the training data for the next iteration, for verification and validation of the system.
Conditions Studied
Interventions
- OTHER Novel Real-time Neonatal Sleep Stage Detection Algorithm
Study Locations (1)
Michigan
- University of Michigan — Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2021-09-01 |
| Est. Completion | 2024-12-19 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04920175
The ClinicalTrials.gov registry entry for NCT04920175 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 39 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Michigan, which has 1,126 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 Neonatal Disease appearing as the primary indexed condition, and to 1 intervention — of which Novel Real-time Neonatal Sleep Stage Detection Algorithm is the first listed. 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: NCT04920175 reports 1 study location spanning 1 distinct geographic area — top geographies include Michigan. 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 NCT04920175 about?
NCT04920175 is a clinical study titled "Real-time State of Vigilance Monitor for the Neonatal Intensive Care Unit". The goal of this observational study is to collect data to develop a complete package (hardware, user interface software and algorithms) that can monitor sleep-wake stages in neonates. Real-time EEG data will be used to develop and refine the prototype monitor's ability to provide direct real-time i...
What is the current status of trial NCT04920175?
This trial is currently completed. The enrollment target is 39 participants. The study started on 2021-09-01. Estimated completion is 2024-12-19.
What conditions does trial NCT04920175 study?
This clinical trial studies the following conditions: Neonatal Disease, Sleep Disturbance in Infancy (Disorder). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04920175?
The interventions under investigation include: Novel Real-time Neonatal Sleep Stage Detection Algorithm (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04920175?
This trial is sponsored by University of Michigan, which has 1,126 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04920175 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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