Vibro-Tactile Stimulation for Neonatal Apnea

(APNeA Trial)

Overseen By Rachel L. Benz, Clinical Research Nurse Manager, MSN

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Major malformation, Neuromuscular condition, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 hours

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a gentle vibration device called the Closed-loop Vibro-Tactile Stimulator, designed to prevent or reduce breathing pauses and slow heart rates in premature babies. The device activates upon predicting or detecting these episodes, aiming to maintain steady breathing in infants. Babies who have recently experienced breathing pauses with slow heart rates, are not on breathing support, and were born very early (before 32 weeks) might be suitable candidates. As an unphased trial, this study provides families with a unique opportunity to contribute to innovative research that could enhance care for premature infants.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that this device is safe for pre-term infants?

Research has shown that the vibrotactile stimulation system is safe for newborns. Early results from studies indicate that it effectively treats apnea, which are pauses in breathing, without harming the skin or nerves. Another study confirmed these findings, showing that the system can stop apnea episodes with little disturbance to the baby. Overall, the system appears well-tolerated, with no major safety concerns reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for neonatal apnea involve medications or respiratory support like continuous positive airway pressure (CPAP) to help keep the baby's airways open. Unlike these standard options, the closed-loop Vibro-Tactile Stimulator offers a non-invasive approach that uses gentle vibrations to stimulate the baby’s skin when an apnea or bradycardia episode is predicted or detected. This method could reduce reliance on more invasive procedures and medications, potentially leading to fewer side effects. Researchers are excited because this innovative approach may provide a more natural way to help newborns regulate their breathing without the need for additional equipment or drugs.

What evidence suggests that this vibro-tactile stimulator is effective for neonatal apnea?

This trial will evaluate the use of a closed-loop Vibro-Tactile Stimulator for neonatal apnea. Research has shown that gentle vibrations can help treat apnea, a condition where newborns stop breathing. Early results from clinical trials suggest that this method can safely wake babies during these breathing pauses. Studies have made the system more portable, allowing use in various settings. Gentle vibrations might offer a safer alternative to traditional methods like tapping to help babies resume normal breathing. This approach has been shown to shorten or even prevent episodes of apnea and slow heart rate. Overall, evidence suggests that gentle vibrations offer a promising way to manage breathing problems in newborns. ^{1 3 4 5 6}

Who Is on the Research Team?

Colm P. Travers Associate Professor of Pediatrics, M.D.

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

This trial is for pre-term infants born before 32 weeks' gestation, who've had apnea with a slow heart rate in the last day and are off breathing support for over 48 hours. Parents must consent to join. Infants with major malformations, neuromuscular issues affecting breathing, or terminal illness can't participate.

Inclusion Criteria

Parents/legal guardians have provided consent for enrollment

I have not needed a ventilator or CPAP machine for over 48 hours.

My baby was born before 32 weeks of pregnancy.

Exclusion Criteria

Presence of a terminal illness or decision to withhold or limit support.

I have a condition that affects my breathing or causes me to stop breathing.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo two 4-hour periods: one with vibrotactile stimulation and one without, to assess the algorithm's efficacy in predicting and interrupting bradycardia episodes.

8 hours

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Closed-loop Vibro-Tactile Stimulator

Trial Overview

The study tests if a Closed-loop Vibro-Tactile Stimulator can prevent or reduce episodes of neonatal apnea (pauses in breathing) and bradycardia (slow heart rate). Infants will be randomly assigned to receive this stimulation or placed in a control group without it.

How Is the Trial Designed?

Group I: Virbrotactile stimulation Experimental Treatment 1 Intervention

Four hours of vibrotactile stimulation via a closed loop device if an apnea or bradycardia episode is predicted or detected.

Group II: Control Placebo Group 1 Intervention

Four hours of no vibrotactile stimulation via the closed loop device if an apnea or bradycardia episode is predicted or detected.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Published Research Related to This Trial

The newly developed apparatus successfully identified apneic events and administered vibrotactile stimulation (VTS) with 100% accuracy in a simulated environment, indicating its potential effectiveness for treating neonatal apnea.

This device offers a noninvasive alternative to traditional nursing hand stimulation, suggesting it could improve the quality of care for neonates experiencing apnea, although it has yet to be tested on actual neonatal patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A computerized system to diagnose and treat neonatal apnea using vibrotactile stimulation. Faille, EO., Setya, A., Eisenfeld, L.[2013]

A new portable vibrotactile device has been developed to help premature infants interrupt central apnea by providing tactile stimulation to their foot, which may help restart their breathing.

Preliminary results indicate that the device effectively stimulates the nervous system, but further testing is needed to confirm its safety and effectiveness before it can be used in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Foot vibrotactile device for central apnea interruption in premature infants. Marayong, P., Mostoufi, MS.[2009]

Citations

1.

withpower.com

withpower.com/trial/phase-apnea-4-2025-91915

Vibro-Tactile Stimulation for Neonatal Apnea

Preliminary data from clinical trials suggest that the vibrotactile stimulation system is both safe and effective in treating apnea in newborns by arousing them ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/12613292/

Vibrotactile stimulation system to treat apnea of prematurity

We modified a system that uses vibrotactile stimulation (VTS) to treat apnea (a cessation of respiration) in neonates in order to make the system more portable.

3.

array.aami.org

array.aami.org/doi/pdf/10.2345/0899-8205%282003%2937%5B34%3AVSSTTA%5D2.0.CO%3B2

Vibrotactile Stimulation System to Treat Apnea of Prematurity

We modified a system that uses vibrotactile stimulation (VTS) to treat apnea (a cessation of respiration) in neonates in order to make the system more portable ...

4.

researchgate.net

researchgate.net/publication/258850099_A_computerized_system_to_diagnose_and_treat_neonatal_apnea_using_vibrotactile_stimulation

A computerized system to diagnose and treat neonatal ...

Vibrotactile stimulation (VTS) maybe an effective, safer alternative to nursing hand stimulation in treating neonatal apnea. We therefore ...

5.

frontiersin.org

frontiersin.org/journals/pediatrics/articles/10.3389/fped.2018.00045/full

Effect of Tactile Stimulation on Termination and Prevention ...

Tactile stimulation, manual or mechanical, has been shown to shorten the duration of apnea, hypoxia, and or bradycardia or even prevent an apnea.

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03651648

Apnea Treatment in Premature Infants Using an Automatic ...

The main hypothesis behind the SENSITACT system is that kinesthetic stimulation can terminate apneas-bradycardias with minimal patient arousal. The aim is to ...