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NCT Number: NCT07704320

Clinical Assessment of the BreathAlert Device in Monitoring Apneic Episodes

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.

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Key information

Conditions

Apnea Infant

Age range

0 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Treatment and study plan

BreathAlert (low cost respiratory rate and apnea monitor)

Device

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

Primary outcomes

  1. Accuracy of BreathAlert

    Time frame: Maximum of one week

Study contacts

Contact information is provided by the study sponsor or research team.

Jennifer Plante

CONTACT

[email protected]

17133484167

Sponsors and collaborators

Lead sponsor

William Marsh Rice University

Other

Collaborators

  • Kamuzu University of Health Sciences

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2027
Study completion
2028
First posted
Jul 15, 2026
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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