Apnea NeonatalAPNeANCT06852053
Application to Predict Neonatal Apnea With Bradycardia
A study testing Closed-loop Vibro-Tactile Stimulator in people with Apnea Neonatal and Bradycardia Neonatal, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
This purpose of this study is to reduce or stop apneas and bradycardias in pre-term infants, before they occur using gentle stimulation. Read more about this study
- Who is it for?
- Ages 22 to 32 weeks
- Conditions the study is for
- Apnea Neonatal, Bradycardia Neonatal
- What is being tested?
- Closed-loop Vibro-Tactile Stimulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Sep 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 32 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- a major malformation or a neuromuscular condition that affects respiration or causes apnea, or terminal illness or decision to withhold or limit support.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35209
Rachel L Benz Clinical Research Nurse Manager, MSN, 205-934-2184, rlbenz@uabmc.edu
Kimberly M. Armstead Clinical Research Coordinator III, B.S., 205-934-0095, karmstead@uabmc.edu
About this study
Official title: Application to Predict Neonatal Apnea With Bradycardia (APNeA Study)
This purpose of this study is to reduce or stop apneas and bradycardias in pre-term infants, before they occur using gentle stimulation.
Read the 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
- Being tested
- Closed-loop Vibro-Tactile Stimulator, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closed-loop Vibro-Tactile StimulatorDevice
Vibro-Tactile stimulation when bradycardia is predicted or predicted.
ControlDevice
Sham closed-loop vibrotactile stimulator
| Study group | Role | What they receive |
|---|---|---|
| Virbrotactile stimulation | Experimental | Four hours of vibrotactile stimulation via a closed loop device if an apnea or bradycardia episode is predicted or detected. Receives: Device: Closed-loop Vibro-Tactile Stimulator |
| Control | Sham comparator | Four hours of no vibrotactile stimulation via the closed loop device if an apnea or bradycardia episode is predicted or detected. Receives: Device: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bradycardia <100 beats per minute ≥ 10 seconds
The frequency of episodes of bradycardia (heart rate less than 100 of ≥ 10 seconds) in either study arm during the study period.
Measured: 4-hours on either intervention.
Secondary outcomes (15)
Bradycardia <60 beats per minute ≥ 5 seconds
The frequency of episodes of bradycardia (heart rate <60 beats per minute ≥ 5 seconds) in either study arm during the study period.
Measured: 4 hours in either intervention.
Bradycardia <60 beats per minute ≥ 10 seconds
The frequency of episodes of bradycardia (heart rate <60 beats per minute ≥ 10 seconds) in either study arm during the study period.
Measured: 4 hours on either intervention.
Bradycardia <80 beats per minute ≥ 5 seconds
The frequency of episodes of bradycardia (heart rate <80 beats per minute ≥ 5 seconds) in either study arm during the study period.
Measured: 4 hours on either intervention.
Bradycardia <80 beats per minute ≥ 10 seconds
The frequency of episodes of bradycardia (heart rate <80 beats per minute ≥ 10 seconds) in either study arm during the study period.
Measured: 4 hours on either intervention.
Proportion of time with Bradycardia < 100 beats per minute
The total proportion of time with bradycardia during the study period on either intervention with a heartrate of <100 beats per minute.
Measured: 4 hours on either intervention.
Hypoxemia <85% for ≥ 5 seconds
The frequency of episodes of hypoxemia (oxygen saturations <85% for ≥ 5 seconds) in either study arm during the study period.
Measured: 4 hours on either intervention.
Hypoxemia <85% for ≥ 10 seconds
The frequency of episodes of hypoxemia (oxygen saturations <85% for ≥ 10 seconds) in either study arm during the study period.
Measured: 4 hours on either intervention.
Hypoxemia <90% for ≥ 5 seconds
The frequency of episodes of hypoxemia (oxygen saturations <90% for ≥ 5 seconds) in either study arm during the study period.
Measured: 4 hours on either intervention.
Hypoxemia <90% for ≥ 10 seconds
The frequency of episodes of hypoxemia (oxygen saturations <90% for ≥ 10 seconds) in either study arm during the study period.
Measured: 4 hours on either intervention.
Hypoxemia <80% for ≥ 5 seconds
The frequency of episodes of hypoxemia (oxygen saturations <80% for ≥ 5 seconds) in either study arm during the study period.
Measured: 4 hours on either intervention.
Hypoxemia <80% for ≥ 10 seconds
The frequency of episodes of hypoxemia (oxygen saturations <80% for ≥ 10 seconds) in either study arm during the study period.
Measured: 4 hours on either intervention.
Proportion of time with hypoxemia < 90%
The total proportion of time with oxygen saturations <90% during the study period on either intervention.
Measured: 4 hours on either intervention.
Bradycardia prediction time
The number of seconds ahead of routine patient monitors at which the device algorithm predicted bradycardia in either group.
Measured: 4 hours on either intervention.
Bradycardia prediction accuracy
The area under the curve for the true prediction rate over the false alarm rate in the control group.
Measured: 4 hours on sham control.
Proportion of time with hypoxemia < 85%
The total proportion of time with oxygen saturations <85% during the study period on either intervention.
Measured: 4 hours on either intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start29 Sep 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Apnea NeonatalStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Colm Travers, University of Alabama at Birmingham
- Investigators
- Colm P. Travers Associate Professor of Pediatrics, M.D., Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06852053
- Sponsor's protocol ID
- 300008477
- Other IDs
- UAB
- Acronym
- APNeA
- Status last verified
- Sep 2026
- First submitted
- 24 Feb 2025
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Deidentified individual participant data will be made available upon publication through a data use agreement to researchers who provide a methodologically sound proposal for use in achieving the goals of the approved proposal. Proposals should be submitted to cptravers@uabmc.edu.
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application to Predict Neonatal Apnea With Bradycardia (APNeA Study)
- ClinicalTrials.gov ID
- NCT06852053
- Acronym / sponsor ID
- APNeA / 300008477
- Conditions
- Apnea Neonatal, Bradycardia Neonatal
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 29 Sep 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 28 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virbrotactile stimulation | Experimental | Device: Closed-loop Vibro-Tactile StimulatorFour hours of vibrotactile stimulation via a closed loop device if an apnea or bradycardia episode is predicted or detected. |
| Control | Sham comparator | Device: ControlFour hours of no vibrotactile stimulation via the closed loop device if an apnea or bradycardia episode is predicted or detected. |
Who may qualify
- Ages
- 22 to 32 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- a major malformation or a neuromuscular condition that affects respiration or causes apnea, or terminal illness or decision to withhold or limit support.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Closed-loop Vibro-Tactile StimulatorVibro-Tactile stimulation when bradycardia is predicted or predicted. | Device | Virbrotactile stimulation |
| ControlSham closed-loop vibrotactile stimulator | Device | Control |
Primary outcome
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.
15 secondary outcomes
Bradycardia <60 beats per minute ≥ 5 seconds
Time frame: 4 hours in either intervention.
Bradycardia <60 beats per minute ≥ 10 seconds
Time frame: 4 hours on either intervention.
Bradycardia <80 beats per minute ≥ 5 seconds
Time frame: 4 hours on either intervention.
Bradycardia <80 beats per minute ≥ 10 seconds
Time frame: 4 hours on either intervention.
Proportion of time with Bradycardia < 100 beats per minute
Time frame: 4 hours on either intervention.
Hypoxemia <85% for ≥ 5 seconds
Time frame: 4 hours on either intervention.
Hypoxemia <85% for ≥ 10 seconds
Time frame: 4 hours on either intervention.
Hypoxemia <90% for ≥ 5 seconds
Time frame: 4 hours on either intervention.
Hypoxemia <90% for ≥ 10 seconds
Time frame: 4 hours on either intervention.
Hypoxemia <80% for ≥ 5 seconds
Time frame: 4 hours on either intervention.
Hypoxemia <80% for ≥ 10 seconds
Time frame: 4 hours on either intervention.
Proportion of time with hypoxemia < 90%
Time frame: 4 hours on either intervention.
Bradycardia prediction time
Time frame: 4 hours on either intervention.
Bradycardia prediction accuracy
Time frame: 4 hours on sham control.
Proportion of time with hypoxemia < 85%
Time frame: 4 hours on either intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: Yes. Deidentified individual participant data will be made available upon publication through a data use agreement to researchers who provide a methodologically sound proposal for use in achieving the goals of the approved proposal. Proposals should be submitted to cptravers@uabmc.edu.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Colm P. Travers Associate Professor of Pediatrics, M.D. principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Closed-loop Vibro-Tactile Stimulator in people with Apnea Neonatal and Bradycardia Neonatal, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rachel L. Benz, Clinical Research Nurse Manager, MSN (205-934-2184, rlbenz@uabmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bradycardia <100 beats per minute ≥ 10 seconds (time frame: 4-hours on either intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.