Assessment of the Accuracy of the Non-invasive Wireless Armband Gabi Baby Band for Continuous Vital Parameters Monitoring in Infants and Young Children (WAGSC1)

Gabi SmartCare

Status: Completed

Conditions: Blood Oxygen Desaturations; Sleep-Disordered Breathing

Treatments: Device: Gabi Baby Band

Study type: Observational

Funder types: Industry

Identifiers

NCT04886583

WAGSC1

Details and patient eligibility

About

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.

Enrollment: 99 patients

Sex: All

Ages: Under 5 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Infants and children under 5 years of age
• PSG is required per standard of care
• Signature of consent form

Exclusion criteria

• Children having already done the PSG wearing GBB for this study
• Epileptic children (due to high motion/artifacts during sleep)
• Weight below 2.5 kg

Trial design

99 participants in 1 patient group

Gabi Baby Band

Description:

GSC 1

Treatment:

Device: Gabi Baby Band