NCT06852053

Application to Predict Neonatal Apnea With Bradycardia

Application to Predict Neonatal Apnea With Bradycardia (APNeA Study)

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 22 Weeks – 32 Weeks
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Apnea Neonatal
• Bradycardia Neonatal

Interventions

Type	Name	Description
DEVICE	Closed-loop Vibro-Tactile Stimulator	Vibro-Tactile stimulation when bradycardia is predicted or predicted.
DEVICE	Control	Sham closed-loop vibrotactile stimulator

Timeline

• Start date: 2026-07-01
• Primary completion: 2026-12-31
• Completion: 2027-12-31
• First posted: 2025-02-28
• Last updated: 2026-01-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study