ClinicalTrials.gg
RecruitingNCT07704320Updated Nov 6, 2026

Clinical Assessment of the BreathAlert Device in Monitoring Apneic Episodes

An observational study in Apnea Infant, sponsored by William Marsh Rice University. Recruiting at 1 site in Malawi. Open to participants aged 0 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-11-06.

Sponsored by William Marsh Rice University · Observational

From the registry’s dates

  • Started Mar 2017; still recruiting 9 years 8 months later.
Updated Nov 6, 2026Primary outcomes revisedGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
Ages
0 Years to 17 Years
Sex
All
01

Study 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.

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Conditions studied

  • Apnea Infant

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03

In context

Apnea

282 studies on the registry are indexed under Apnea; 54 are open to participants now.

This study's planned enrollment of 60 is close to the median of 60 across 78 observational studies indexed under Apnea.

Browse Apnea studies →

Lead sponsor

William Marsh Rice University is the lead sponsor of 17 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
0 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients in the neonatal or pediatric ward deemed to be at risk for apnea or in need of respiratory rate monitoring

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 for their child to participate.

Exclusion criteria

Exclusion Criteria:

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
60 participants (estimated)
Patient registry
No

Groups and cohorts

  • Patients in the neonatal/pediatric ward at risk for apnea or in need of respiratory rate monitoring

    Device: BreathAlert (low cost respiratory rate and apnea monitor)

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.

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What researchers measure

Primary outcomes

  1. Accuracy of BreathAlert

    Accuracy of BreathAlert respiratory rate measurement compared to visual counting and standard patient monitors

    Time frame: Maximum of one week

07

Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Primary outcomes
1 description edited
What changed in the outcomes
  • DescriptionAccuracy of BreathAlert: how it is measured was reworded
Nov 6, 2026
Show all 1 update
  1. Nov 6, 2026
    Primary outcomes 1 description edited
    What changed in the outcomes
    • DescriptionAccuracy of BreathAlert: how it is measured was reworded
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07704320
Lead sponsor
William Marsh Rice University
Collaborators
Kamuzu University of Health Sciences
Responsible party
Sponsor
First posted
Jul 15, 2026
Start date
Mar 11, 2017
Primary completion
Dec 2027 (estimated)
Completion
Jun 2028 (estimated)
Last update
Nov 6, 2026

Study contacts

Jennifer Plante
Contact
jcarns@rice.edu
17133484167

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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