About this trial
In this study, the hypothesis being explored is that peak VO2 and potentially other CPET parameters can be accurately estimated from biosignals (namely, motion from accelerometers and cardiopulmonary variables from EKG) collected during activities of daily living using FDA-cleared wearable biosensors worn by study participants. This study will aim to collect data using wearable biosensors from standard of care patients toward the development of an algorithm that can estimate peak VO2 (eVO2peak) from biosensor data. In addition, this study will explore to further develop other estimated measurements typically reported in CPET, such as VE/VCO2 slope, as well as selected and measures of Left Ventricular Function (diastolic and systolic) typically reported in echocardiogram; instead using wearable biosensors from standard of care testing. A total of 2000 participants will be enrolled including: (Normal) 100 participants, self-reported healthy male and female participants aged 18 to 80 and (Standard of Care) 1900 participants.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Willing and able to comply with protocol procedures and available for the duration of the study.
Willing to sign and date informed consent document for study participation.
Participant is undergoing the Cardiopulmonary Exercise Test (CPET), or an echocardiogram (Echo), or both CPET and Echo as Standard of Care
Disqualifiers
Participant is pregnant, lactating or ≤30 days post-partum.
Participant has limited or no intrinsic sinus node function (i.e. chronic atrial pacing).
Barostim (™) or similar noncardiac electrical pulse generating device in situ.
Any history of allergy to adhesive
Trial population
Participant is undergoing the Cardiopulmonary Exercise Test (CPET), or an echocardiogram (Echo), or both CPET and Echo as Standard of Care
Trial design
Case-control
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Collect development and validation data for a peak VO2 (eVO2peak) machine learning algorithm and to evaluate the performance of the algorithm.
Develop an Estimated Peak VO2 (eVO2peak) algorithm which will estimate a participant's peak VO2 value using data collected from physiological wearable biosensors (ECG \& Activity).
Secondary outcomes
Further develop other estimated measurements typically reported in CPET and echocardiogram using wearable biosensors
Further develop other estimated measurements typically reported in CPET, such as VE/VCO2 slope, as well as selected and measures of Left Ventricular Function (diastolic and systolic) typically reported in echocardiogram; instead using wearable biosensors from standard of care testing.