Status:
COMPLETED
Assessment of the Accuracy of the Non-invasive Wireless Armband Gabi Baby Band for Continuous Vital Parameters Monitoring in Infants and Young Children
Lead Sponsor:
Gabi SmartCare
Conditions:
Blood Oxygen Desaturations
Sleep-Disordered Breathing
Eligibility:
All Genders
Up to 5 years
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...
Eligibility Criteria
Inclusion
- Infants and children under 5 years of age
- PSG is required per standard of care
- Signature of consent form
Exclusion
- 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
Key Trial Info
Start Date :
April 30 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 28 2022
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT04886583
Start Date
April 30 2021
End Date
February 28 2022
Last Update
April 4 2022
Active Locations (3)
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1
Hopital Universitaire Des Enfants Reine Fabiola
Jette, Brussels Capital, Belgium, 1020
2
CHU Marie Curie
Charleroi, Hainaut, Belgium, 6042
3
CHC Montlégia
Liège, Belgium, 4000