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

January 21, 2025 updated by: John Barks, University of Michigan
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Use Case: Disruption of sleep is a common experience of hospitalized patients of all ages, especially if they are in an intensive care unit (ICU); infants in the NICU often stay weeks to months. The quality of neonatal sleep is strongly associated with later neurodevelopment. Abnormal sleep quality in neonates is associated with less attention orienting at 4 months, increased distractibility, decreased developmental function at 12-24 months, and lower emotional regulation and cognitive development at age 5. Yet disruptions to sleep are frequent: the study team has found that NICU neonates are handled by staff with a median interval of 2.3 min. Handling occurred across all sleep-wake stages and frequently resulted in arousals, awakenings, and respiratory events.

The study will employ multiple levels of noise reduction and signal quality assessment, tailored to the specific needs of the algorithm and to the NICU environment. The final algorithm will include four sleep-wake stages (awake, quiet/non-REM sleep, active/REM sleep, indeterminate/transitional sleep). The complete algorithm is intended to do what no existing algorithm does, as it uniquely combines the assessment of data quality, ability to run real-time on un-curated data, and identification of four sleep-wake stages. In this observational study, validation of the monitor "read-out" in comparison to the gold standard polysomnogram happens offline, after the completion of data collection from the subject.

Because this is an observational study to develop and validate a new physiologic monitoring modality (the bedside sleep monitor), there is no subject intervention. No change in care for these study subjects is envisioned to result from use of this prototype monitor. It is hoped that the proposed technology will create a unique solution that will one day be deployed in the NICU.

Potential Future Research Use of Monitor: The study team hypothesizes that adjusting the timing of NICU patient contact to avoid multiple sleep disruptions might improve sleep in the NICU, which could then lead to better neurodevelopmental outcomes. However, the efficacy of this approach would need to be proved in randomized controlled trials. The conduct of such a future randomized clinical trial would be facilitated by availability of a real-time, objective monitor of sleep-wake states like what the study team proposes to develop. However, the present observational study serves as an initial stage of research that would lead up to that kind of trial.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
39

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 day to 1 year (Child)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Newborns admitted to the Newborn ICU in C&W Mott Hospital

Description

Inclusion Criteria:

  • Admitted to the Newborn ICU in C&W Mott Hospital
  • >/= 30 weeks gestational age at the time of birth (>/= 33 weeks post-conceptional age at enrollment)

Exclusion Criteria:

  • Any diagnosis, patient care, or anticipated patient care that is likely to interfere with the 12 hour recording or would make the recording dangerous to the participant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
NICU Cohort
Participants will undergo a standard polysomnogram
Other: Novel Real-time Neonatal Sleep Stage Detection Algorithm
Comparison of Novel Real-time Neonatal Sleep Stage Detection Algorithm to gold standard concurrent polysomnogram.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Negative predictive value (NPV) for detection of sleep (any stage)
Time Frame: 12 hours
Negative predictive value of monitor compared to gold-standard polysomnogram
12 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
NPV for detection of REM sleep
Time Frame: 12 hours
Negative predictive value of monitor compared to gold-standard polysomnogram
12 hours
NPV for detection of non-REM sleep
Time Frame: 12 hours
Negative predictive value of monitor compared to gold-standard polysomnogram
12 hours
Positive predictive value (PPV) of Sleep
Time Frame: 12 hours
Positive predictive value of monitor compared to gold-standard polysomnogram
12 hours
Positive predictive value (PPV) of REM sleep
Time Frame: 12 hours
Positive predictive value of monitor compared to gold-standard polysomnogram
12 hours
Positive predictive value (PPV) of non-REM sleep
Time Frame: 12 hours
Positive predictive value of monitor compared to gold-standard polysomnogram
12 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Michigan

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Heart, Lung, and Blood Institute (NHLBI)
University of Nebraska

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: John Barks, MD, University of Michigan
  • Principal Investigator: Stephen Gliske, PhD, University of Nebraska

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 19, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 19, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 3, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 3, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 9, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 21, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HUM00187386
  • 1R61HL154095-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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