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Real-time State of Vigilance Monitor for the Neonatal Intensive Care Unit

NCT04920175 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 39

Last updated 2025-01-24

No results posted yet for this 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

  • Sleep Disturbance in Infancy (Disorder)
  • Neonatal Disease

Interventions

OTHER

Novel Real-time Neonatal Sleep Stage Detection Algorithm

Comparison of Novel Real-time Neonatal Sleep Stage Detection Algorithm to gold standard concurrent polysomnogram.

Sponsors & Collaborators

  • University of Nebraska

    collaborator OTHER

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • University of Michigan

    lead OTHER

Principal Investigators

  • John Barks, MD · University of Michigan

  • Stephen Gliske, PhD · University of Nebraska

Eligibility

Min Age
1 Day
Max Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-01
Primary Completion
2024-12-19
Completion
2024-12-19

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04920175 on ClinicalTrials.gov