Application to Predict Neonatal Apnea With Bradycardia (APNeA)

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: Not yet recruiting
• Conditions: Bradycardia Neonatal; Apnea Neonatal
• Intervention / Treatment: Device: Closed-loop Vibro-Tactile Stimulator; Device: Control

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: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: 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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Bradycardia <100 beats per minute ≥ 10 seconds	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

Outcome Measure	Measure Description	Time Frame
Bradycardia <60 beats per minute ≥ 5 seconds	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	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	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	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	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	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	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	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	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	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	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%	The total proportion of time with oxygen saturations <90% during the study period on either intervention.	4 hours on either intervention.
Bradycardia prediction time	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	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%	The total proportion of time with oxygen saturations <85% during the study period on either intervention.	4 hours on either intervention.

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Investigators: Principal Investigator: Colm P. Travers Associate Professor of Pediatrics, M.D., University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: February 24, 2025
• First Submitted That Met QC Criteria: February 24, 2025
• First Posted (Actual): February 28, 2025

Study Record Updates

• Last Update Posted (Actual): January 23, 2026
• Last Update Submitted That Met QC Criteria: January 22, 2026
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Respiratory Tract Diseases; Arrhythmias, Cardiac; Respiration Disorders; Signs and Symptoms, Respiratory; Apnea; Bradycardia
• Other Study ID 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