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

Completed

• Conditions: Blood Oxygen Desaturations; Sleep-Disordered Breathing
• Interventions: Device: Gabi Baby Band

• Registration Number: NCT04886583
• Lead Sponsor: Gabi SmartCare

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-30
• Study First Submitted: 2021-05-03
• Study First Submitted QC: 2021-05-10
• Study First Posted: 2021-05-14
• Primary Completion: 2022-02-28
• Study Completion: 2022-02-28
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-22
• Last Update Posted: 2022-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Gabi Baby Band	Gabi Baby Band	GSC 1

Primary Outcome Measures

Name	Time	Method
to improve the calibration, the correctness and reproducibility of the SpO2 (%) measurements reported by the GBB	12 hours	The primary objective of this pilot study is to improve the calibration, the correctness and reproducibility of the measurements reported by the GBB compared to a standard of care for measuring SpO2 (%) through the recording of raw data with the Gabi Baby Band in parallel with values recorded by medical devices used by the investigation site in its current standard care practice test (during sleep) on infants and children under 5 years old.

Secondary Outcome Measures

Name	Time	Method
to improve the calibration, the correctness and reproducibility of the measurements of the BR (breathing rate; cycle/min) reported by the GBB	12 hours	The primary objective of this pilot study is to improve the calibration, the correctness and reproducibility of the measurements reported by the GBB compared to a standard of care for measuring BR (breathing rate; cycle/min) through the recording of raw data with the Gabi Baby Band in parallel with values recorded by medical devices used by the investigation site in its current standard care practice test (during sleep) on infants and children under 5 years old.
to improve the calibration, the correctness and reproducibility of the measurements of the HR (heart rate; beat/min or bpm) reported by the GBB	12 hours	The primary objective of this pilot study is to improve the calibration, the correctness and reproducibility of the measurements reported by the GBB compared to a standard of care for measuring BR (heart rate; beat/min) through the recording of raw data with the Gabi Baby Band in parallel with values recorded by medical devices used by the investigation site in its current standard care practice test (during sleep) on infants and children under 5 years old.

Trial Locations

Locations (3)

Hopital Universitaire Des Enfants Reine Fabiola; 🇧🇪 Jette, Brussels, Belgium

CHU Marie Curie; 🇧🇪 Charleroi, Hainaut, Belgium

CHC Montlégia; 🇧🇪 Liège, Belgium