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

Sleep-Disordered Breathing Clinical Trial

— WAGSC1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04886583
• Other study ID #: WAGSC1
• Status: Completed
• Start date: April 30, 2021
• Est. completion date: February 28, 2022

Study information

• Verified date: March 2022
• Source: Gabi SmartCare
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: February 28, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Sleep Apnea Syndromes
• Sleep-Disordered Breathing

Intervention

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

Locations

Country	Name	City	State
Belgium	CHU Marie Curie	Charleroi	Hainaut
Belgium	Hopital Universitaire Des Enfants Reine Fabiola	Jette	Brussels
Belgium	CHC Montlégia	Liège

Sponsors (1)

Lead Sponsor	Collaborator
Gabi SmartCare

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	to improve the calibration, the correctness and reproducibility of the SpO2 (%) measurements reported by the GBB	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.	12 hours
Secondary	to improve the calibration, the correctness and reproducibility of the measurements of the BR (breathing rate; cycle/min) reported by the GBB	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.	12 hours
Secondary	to improve the calibration, the correctness and reproducibility of the measurements of the HR (heart rate; beat/min or bpm) reported by the GBB	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.	12 hours