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

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

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.

Study Overview

• Status: Completed
• Conditions: Sleep-Disordered Breathing; Blood Oxygen Desaturations
• Intervention / Treatment: Device: Gabi Baby Band

• Study Type: Observational
• Enrollment (Actual): 99

Contacts and Locations

Study Locations

• Belgium
  • Liège, Belgium, 4000
    • CHC MontLégia
  • Brussels
    • Jette, Brussels, Belgium, 1020
      • Hôpital Universitaire des Enfants Reine Fabiola
  • Hainaut
    • Charleroi, Hainaut, Belgium, 6042
      • CHU Marie Curie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Children under 5 years old who need to undergo a polysomnographic exam, as per standard of care, and admitted in the PSG paediatrics service for at least 1 night after proper medical examination and diagnostic by a qualified physician.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Gabi Baby Band; GSC 1	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Gabi SmartCare

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2021
• Primary Completion (Actual): February 28, 2022
• Study Completion (Actual): February 28, 2022

Study Registration Dates

• First Submitted: May 3, 2021
• First Submitted That Met QC Criteria: May 10, 2021
• First Posted (Actual): May 14, 2021

Study Record Updates

• Last Update Posted (Actual): April 4, 2022
• Last Update Submitted That Met QC Criteria: March 22, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes
• Other Study ID Numbers: WAGSC1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No