MedTrace Logo

Assessment of the Accuracy of the Non-invasive Wireless Armband Gabi Baby Band for Continuous Vital Parameters Monitoring in Infants and Young Children

NCT04886583 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 99

Last updated 2022-04-04

No results posted yet for this study

Summary

During a polysomnography test (PSG) previously prescribed by a physician, the patient also wears the Gaby Baby Band (GBB) during an entire night of sleep. After the test, data from the device and from the PSG (HR, SpO2, BR) will be saved and analysed in the aim to assess the actual accuracy of the GBB with golden standard values (ECG, Oximeter, belly belt). In a second analysis, the aim is to improve the accuracy of the GBB algorithm.

Conditions

  • Blood Oxygen Desaturations
  • Sleep-Disordered Breathing

Interventions

DEVICE

Gabi Baby Band

Every enrolled patient must wear the Gaby Baby Band on the left arm in the aim to perform data analytics after the test has been performed

Sponsors & Collaborators

  • Gabi SmartCare

    lead INDUSTRY

Eligibility

Max Age
5 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-30
Primary Completion
2022-02-28
Completion
2022-02-28

Countries

  • Belgium

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04886583 on ClinicalTrials.gov