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Clinical Assessment of the BreathAlert Device in Monitoring Apneic Episodes

Pilot Clinical Assessment of the BreathAlert Device in Monitoring Apneic Episodes in Infants at Risk for Apnea

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07704320
Enrollment
60
Registered
2026-07-15
Start date
2017-03-11
Completion date
2028-06-01
Last updated
2026-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Apnea Infant

Brief summary

A team of researchers at Rice University in partnership with clinicians at Queen Elizabeth Central Hospital created BreathAlert, a low cost battery-powered monitor that detects and corrects apnea. This study evaluates the ability of BreathAlert to detect respiration and apneic episodes in infants. Data from BreathAlert and vital signs monitors is collected. The performance of BreathAlert in respiration and apnea detection is compared with traditional vital sign monitoring which may include temperature, heart rate, EKG, respiratory rate, SPO2 and impedance pneumography.

Interventions

DEVICEBreathAlert (low cost respiratory rate and apnea monitor)

A BreathAlert device is attached to the subject. Data from BreathAlert and vital signs monitors is collected.

Sponsors

William Marsh Rice University
Lead SponsorOTHER
Kamuzu University of Health Sciences
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
0 Years to 17 Years
Healthy volunteers
No

Inclusion criteria

* Participants will be identified using the eligibility criteria stipulated below. 1. The patient is currently being treated at QECH in the neonatal or pediatric ward. 2. The patient is deemed to be at risk for apnea or in need of respiratory rate monitoring. 3. A BreathAlert device is available for use while the patient is at risk for apnea. 4. The patient's caregiver has provided informed consent for their child to participate.

Design outcomes

Primary

MeasureTime frame
Accuracy of BreathAlertMaximum of one week

Countries

Malawi

Contacts

CONTACTJennifer Plante
jcarns@rice.edu17133484167

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 16, 2026