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NCT04920175 · ClinicalTrials.gov registry record
Real-time State of Vigilance Monitor for the Neonatal Intensive Care Unit
A clinical trial of Neonatal Disease and Sleep Disturbance in Infancy (Disorder), sponsored by University of Michigan.
- Completed
- Registry status
- 39
- Enrollment target
- 1
- Study location
NCT04920175: Completed study of Neonatal Disease and Sleep Disturbance in Infancy (Disorder), sponsored by University of Michigan.
NCT04920175 is a study of Neonatal Disease and Sleep Disturbance in Infancy (Disorder) that has completed, run by University of Michigan. The registered enrollment target is 39 participants. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04920175, a study of Neonatal Disease and Sleep Disturbance in Infancy (Disorder), has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- 39 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
Negative predictive value of monitor compared to gold-standard polysomnogram
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 |
What the finished NCT04920175 record still lists
NCT04920175 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 39 participants, a relatively small participant target.
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.
NCT04920175 reports a single indexed study location in Michigan.
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).
What interventions are being tested in trial NCT04920175?
The interventions under investigation include: Novel Real-time Neonatal Sleep Stage Detection Algorithm (OTHER).
Who is sponsoring clinical trial NCT04920175?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
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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