NCT04886583

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

Preliminary Multi-centric Clinical Study Assessing the Accuracy of the Non-invasive Wireless Armband Gabi Baby Band for the Continuous Monitoring and Recording of Vital Physiological Parameters on Infants and Young Children by Comparison of Simultaneous Polysomnographic Recording During Standard of Care Hospitalisation

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 99 (actual)
• Sponsor: Gabi SmartCare · Industry
• Sex: All
• Age: 5 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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

Timeline

• Start date: 2021-04-30
• Primary completion: 2022-02-28
• Completion: 2022-02-28
• First posted: 2021-05-14
• Last updated: 2022-04-04

Locations

3 sites across 1 country: Belgium