Application to Predict Neonatal Apnea With Bradycardia (APNeA)

July 2, 2026 updated by: Colm Travers, University of Alabama at Birmingham

Application to Predict Neonatal Apnea With Bradycardia (APNeA Study)

This purpose of this study is to reduce or stop apneas and bradycardias in pre-term infants, before they occur using gentle stimulation.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

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

This will be a randomized cross-over trial that will use additional ECG leads connected to a novel device and laptop to determine the accuracy and efficacy of an algorithm to predict, detect, and interrupt episodes of bradycardia for two 4-hour periods. There will be a 4-hour period without vibro-tactile stimulation and a 4-hour period with vibro-tactile stimulation when episodes are predicted or detected.

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.
Interventional

Enrollment (Estimated)

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.
25

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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.
  • Name: Rachel L. Benz, Clinical Research Nurse Manager, MSN
  • Phone Number: 205-934-2184
  • Email: rlbenz@uabmc.edu

Study Contact Backup

  • Name: Kimberly M. Armstead Clinical Research Coordinator III, B.S.
  • Phone Number: 205-934-0095
  • Email: karmstead@uabmc.edu

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • University of Alabama at Birmingham
        • Contact:
          • Kimberly M. Armstead Clinical Research Coordinator III, B.S.
          • Phone Number: 205-934-0095
          • Email: karmstead@uabmc.edu
        • Contact:
          • Rachel L Benz Clinical Research Nurse Manager, MSN
          • Phone Number: 205-934-2184
          • Email: rlbenz@uabmc.edu
        • Principal Investigator:
          • Colm P. Travers, M.D.

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

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Documented episodes of apnea with bradycardia over the previous 24 hours.
  • Off ventilatory support/NCPAP for > 48 hours prior to study entry
  • Gestational age < 32 0/7 weeks' gestation at birth
  • Parents/legal guardians have provided consent for enrollment

Exclusion Criteria:

  • a major malformation or a neuromuscular condition that affects respiration or causes apnea, or terminal illness or decision to withhold or limit support.

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
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.
Experimental: Virbrotactile stimulation
Four hours of vibrotactile stimulation via a closed loop device if an apnea or bradycardia episode is predicted or detected.
Device: Closed-loop Vibro-Tactile Stimulator
Vibro-Tactile stimulation when bradycardia is predicted or predicted.
Sham Comparator: Control
Four hours of no vibrotactile stimulation via the closed loop device if an apnea or bradycardia episode is predicted or detected.
Device: Control
Sham closed-loop vibrotactile stimulator

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
Bradycardia <100 beats per minute ≥ 10 seconds
Time Frame: 4-hours on either intervention.
The frequency of episodes of bradycardia (heart rate less than 100 of ≥ 10 seconds) in either study arm during the study period.
4-hours on either intervention.

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
Bradycardia <60 beats per minute ≥ 5 seconds
Time Frame: 4 hours in either intervention.
The frequency of episodes of bradycardia (heart rate <60 beats per minute ≥ 5 seconds) in either study arm during the study period.
4 hours in either intervention.
Bradycardia <60 beats per minute ≥ 10 seconds
Time Frame: 4 hours on either intervention.
The frequency of episodes of bradycardia (heart rate <60 beats per minute ≥ 10 seconds) in either study arm during the study period.
4 hours on either intervention.
Bradycardia <80 beats per minute ≥ 5 seconds
Time Frame: 4 hours on either intervention.
The frequency of episodes of bradycardia (heart rate <80 beats per minute ≥ 5 seconds) in either study arm during the study period.
4 hours on either intervention.
Bradycardia <80 beats per minute ≥ 10 seconds
Time Frame: 4 hours on either intervention.
The frequency of episodes of bradycardia (heart rate <80 beats per minute ≥ 10 seconds) in either study arm during the study period.
4 hours on either intervention.
Proportion of time with Bradycardia < 100 beats per minute
Time Frame: 4 hours on either intervention.
The total proportion of time with bradycardia during the study period on either intervention with a heartrate of <100 beats per minute.
4 hours on either intervention.
Hypoxemia <85% for ≥ 5 seconds
Time Frame: 4 hours on either intervention.
The frequency of episodes of hypoxemia (oxygen saturations <85% for ≥ 5 seconds) in either study arm during the study period.
4 hours on either intervention.
Hypoxemia <85% for ≥ 10 seconds
Time Frame: 4 hours on either intervention.
The frequency of episodes of hypoxemia (oxygen saturations <85% for ≥ 10 seconds) in either study arm during the study period.
4 hours on either intervention.
Hypoxemia <90% for ≥ 5 seconds
Time Frame: 4 hours on either intervention.
The frequency of episodes of hypoxemia (oxygen saturations <90% for ≥ 5 seconds) in either study arm during the study period.
4 hours on either intervention.
Hypoxemia <90% for ≥ 10 seconds
Time Frame: 4 hours on either intervention.
The frequency of episodes of hypoxemia (oxygen saturations <90% for ≥ 10 seconds) in either study arm during the study period.
4 hours on either intervention.
Hypoxemia <80% for ≥ 5 seconds
Time Frame: 4 hours on either intervention.
The frequency of episodes of hypoxemia (oxygen saturations <80% for ≥ 5 seconds) in either study arm during the study period.
4 hours on either intervention.
Hypoxemia <80% for ≥ 10 seconds
Time Frame: 4 hours on either intervention.
The frequency of episodes of hypoxemia (oxygen saturations <80% for ≥ 10 seconds) in either study arm during the study period.
4 hours on either intervention.
Proportion of time with hypoxemia < 90%
Time Frame: 4 hours on either intervention.
The total proportion of time with oxygen saturations <90% during the study period on either intervention.
4 hours on either intervention.
Bradycardia prediction time
Time Frame: 4 hours on either intervention.
The number of seconds ahead of routine patient monitors at which the device algorithm predicted bradycardia in either group.
4 hours on either intervention.
Bradycardia prediction accuracy
Time Frame: 4 hours on sham control.
The area under the curve for the true prediction rate over the false alarm rate in the control group.
4 hours on sham control.
Proportion of time with hypoxemia < 85%
Time Frame: 4 hours on either intervention.
The total proportion of time with oxygen saturations <85% during the study period on either intervention.
4 hours on either intervention.

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 Alabama at Birmingham

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: Colm P. Travers Associate Professor of Pediatrics, M.D., University of Alabama at Birmingham

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 (Estimated)

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, 2026

Primary Completion (Estimated)

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 31, 2026

Study Completion (Estimated)

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 31, 2027

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).
February 24, 2025

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.
February 24, 2025

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.
February 28, 2025

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.
July 7, 2026

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.
July 2, 2026

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.
October 1, 2025

More Information

Terms related to this study

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.
  • 300008477
  • UAB (Other Identifier: UAB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Deidentified individual participant data will be made available upon publication through a data use agreement to researchers who provide a methodologically sound proposal for use in achieving the goals of the approved proposal. Proposals should be submitted to cptravers@uabmc.edu.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

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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