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

NCT04886583 | Completed

• 1 other identifier: WAGSC1
• Study Type: observational
• Target: 99
• Locations: 1 country
• Sites: 3

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.

Conditions

Blood Oxygen Desaturations; Sleep-Disordered Breathing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

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

  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

  12 hours

Study Arms (1)

Gabi Baby Band

GSC 1

Device: Gabi Baby Band

Interventions

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

Gabi Baby Band

Eligibility Criteria

• Age: Up to 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gabi SmartCare: lead

Study Sites (3)

Hopital Universitaire Des Enfants Reine Fabiola

Jette, Brussels Capital, 1020, Belgium

Location

CHU Marie Curie

Charleroi, Hainaut, 6042, Belgium

Location

CHC Montlégia

Liège, 4000, Belgium

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2021
• First Posted: May 14, 2021
• Study Start: April 30, 2021
• Primary Completion: February 28, 2022
• Study Completion: February 28, 2022
• Last Updated: April 4, 2022

Record last verified: 2022-03

Locations

BE (3)