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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

99 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-30

Study Completion Date

2022-02-28

Brief Summary

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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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Detailed Description

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Conditions

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Blood Oxygen Desaturations Sleep-Disordered Breathing

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Gabi Baby Band

GSC 1

Gabi Baby Band

Intervention Type 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

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes