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

25 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Closed-loop Vibro-Tactile Stimulator 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 to resume breathing. Additionally, a similar device successfully interrupted apnea episodes in 9 out of 10 cases in premature newborns, indicating its potential effectiveness. ^{1 2 3 4 5}

Is vibro-tactile stimulation safe for use in humans, particularly in newborns?

Preliminary data from studies on vibro-tactile stimulation for treating apnea in newborns suggest that the method is safe. The device is non-invasive and has been used successfully to stimulate breathing in premature infants without reported safety issues. ^{1 2 3 6 7}

How does the Vibro-Tactile Stimulation treatment for neonatal apnea differ from other treatments?

The Vibro-Tactile Stimulation treatment for neonatal apnea is unique because it uses a non-invasive device that delivers gentle vibrations to the infant's body to stimulate breathing. This approach is different from other treatments as it directly targets the nervous system to reinitiate breathing without the need for medication or invasive procedures. ^{1 2 3 8 9}

What is the purpose of this trial?

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

Research Team

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

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Vibrotactile stimulation system to treat apnea of prematurity. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Foot vibrotactile device for central apnea interruption in premature infants. [2009]

3. United States pubmed.ncbi.nlm.nih.gov

Instrumentation for the detection and interruption of apnea episodes for premature newborn. [2020]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Tactile stimulation in very preterm infants and their needs of non-invasive respiratory support. [2022]

5. Ireland pubmed.ncbi.nlm.nih.gov

Repetitive versus standard tactile stimulation of preterm infants at birth - A randomized controlled trial. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Can vibroacoustic stimulation improve the efficiency of a tertiary care antenatal testing unit? [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Response of neonates to vibroacoustic stimulation. [2004]

8. United States pubmed.ncbi.nlm.nih.gov

A computerized system to diagnose and treat neonatal apnea using vibrotactile stimulation. [2013]

9. United States pubmed.ncbi.nlm.nih.gov

Effect of tactile stimulation pulse characteristics on sensation threshold and power consumption. [2019]