Subjects will use the Gabi system on a daily basis for 3 months, each time the subject is resting or asleep. The Gabi system will recording the SpO2, pulse rate, respiratory rate and movements of the subject. The objective of this study is to perform a first assessment of the range of most potentially clinically relevant indications for use of the Gabi system for children \< 6 years old with underlying medical conditions. This is performed by asking HCPs to review the data measured by the Gabi system after taking a medical decision independently from the Gabi data and to assess the potential clinical utility of the Gabi system. The usability of the system will also be assessed throughout questionnaires filled out by the HCPs and by the caregivers. \*During this study, the data collected by the Gabi system are not intended to be used by caregivers or HCPs to take any (medical) decisions.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
101
See arm description
Children's National Hospital
Washington D.C., District of Columbia, United States
Columbia University Irving Medical Center
New York, New York, United States
Universitair Ziekenhuis Antwerpen (UZA)
Antwerp, Belgium
Clinique CHC Montlégia
Liège, Belgium
Clinical Utility
Define the range of most potentially clinically significant indications for use of the Gabi system based on the Gabi system clinical utility assessment per medical condition, assessed throughout Medical Decision Questionnaires and Clinical Utility Questionnaires.
Time frame: Assessed at the end of the 3-month period for each participant
Caregiver Usability
Assess the usability of the Gabi system from the point of view of the caregivers through a Usability Questionnaire.
Time frame: Assessed at the end of the 3-month period for each participant
HCP Usability
Assess the usability of the Gabi system from the point of view of the HCPs through a Usability Questionnaire.
Time frame: Assessed at the end of the 3-month period for each participant
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