Recruiting

Gentle Stimulation

Sponsor:

University of Alabama at Birmingham

Code:

NCT06852053

Conditions

Apnea Neonatal

Bradycardia Neonatal

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

Closed-loop Vibro-Tactile Stimulator

Control

Study Details

Brief summary:

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

Conditions

Apnea Neonatal

Bradycardia Neonatal

Study ID

NCT06852053

Start date

Sep 29, 2026

Status verified date

Sep, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

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 Design

Enrollment

25 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Virbrotactile stimulation

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

sham comparator: Control

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

Interventions

Closed-loop Vibro-Tactile Stimulator

Vibro-Tactile stimulation when bradycardia is predicted or predicted.

Control

Sham closed-loop vibrotactile stimulator

Primary outcome measure

  • Bradycardia <100 beats per minute ≥ 10 seconds [ Time Frame: 4-hours on either intervention. ]

Central Contacts and Locations

Central contacts

Rachel L. Benz, Clinical Research Nurse Manager, MSN

205-934-2184rlbenz@uabmc.edu

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

205-934-0095karmstead@uabmc.edu

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35209

Contacts

Rachel L Benz Clinical Research Nurse Manager, MSN

205-934-2184rlbenz@uabmc.edu

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

205-934-0095karmstead@uabmc.edu

Principal Investigator:

Colm P. Travers, M.D.

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

Oct 2, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-03. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2026-10-02. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.