Blood Oxygen Desaturations, Sleep-Disordered Breathing
Conditions
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.
Interventions
DEVICEGabi 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
Sponsors
Gabi SmartCare
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 5 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| to improve the calibration, the correctness and reproducibility of the SpO2 (%) measurements reported by the GBB | 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
| Measure | Time frame | Description |
|---|---|---|
| to improve the calibration, the correctness and reproducibility of the measurements of the BR (breathing rate; cycle/min) reported by the GBB | 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 | 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. |
Countries
Belgium
Outcome results
None listed