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NCT Number: NCT06852053

Application to Predict Neonatal Apnea With Bradycardia

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

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Key information

Conditions

Apnea Neonatal Bradycardia Neonatal

Age range

22 week–32 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35209, United States

Location contact

Colm P. Travers, M.D.

PRINCIPAL_INVESTIGATOR

Kimberly M. Armstead Clinical Research Coordinator III, B.S.

CONTACT

[email protected]

205-934-0095

Rachel L Benz Clinical Research Nurse Manager, MSN

CONTACT

[email protected]

205-934-2184

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Closed-loop Vibro-Tactile Stimulator

Device

Vibro-Tactile stimulation when bradycardia is predicted or predicted.

Control

Device

Sham closed-loop vibrotactile stimulator

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kimberly M. Armstead Clinical Research Coordinator III, B.S.

CONTACT

[email protected]

205-934-0095

Rachel L. Benz, Clinical Research Nurse Manager, MSN

CONTACT

[email protected]

205-934-2184

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

Application to Predict Neonatal Apnea With Bradycardia (APNeA Study)

Acronym: APNeA

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Feb 28, 2025
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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