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

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.

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Key information

Conditions

Blood Oxygen Desaturations Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders Sleep-Disordered Breathing

Age range

Up to 5 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hopital Universitaire Des Enfants Reine Fabiola, Jette, Brussels Capital, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gabi Baby Band

Device

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

Primary outcomes

to improve the calibration, the correctness and reproducibility of the SpO2 (%) measurements reported by the GBB

Time frame: 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 outcomes

to improve the calibration, the correctness and reproducibility of the measurements of the BR (breathing rate; cycle/min) reported by the GBB

Time frame: 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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Gabi SmartCare

Industry

Registry information

Official study 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

Acronym: WAGSC1

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2022
First posted: May 14, 2021
Registry last updated: Apr 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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