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Recruiting
NCT05678530
Estimated VO2Max Validation
Conditions: Heart Failure, Healthy
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: 1
Enrollment: 400
Sponsor: physIQ, Inc.
Location: United States
Summary
In this study, the hypothesis being explored is that VO2Max and 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 wearable biosensors worn by study participants.
This study will aim to collect development and validation data for a machine learning algorithm and to evaluate the performance of the algorithm.
A total of 300 participants will be enrolled including: (Normal) 200 participants, self-reported healthy male and female participants aged 18 to 80 and (Standard of Care) 100 participants
Eligibility Criteria
Inclusion Criteria:Has a clinical indication for investigation of functional capacity through cardiopulmonary exercise testingWilling and able to comply with protocol proceduresWilling to sign and date informed consent document for study participationExclusion Criteria:Participant has cognitive or physical limitations that, in the opinion of the investigator, limits the participant's ability to fully follow study procedures and/or reach and respiratory exchange ratio of 1.0Participant has an allergy to the adhesive used on the VitalPatchParticipant is pregnant, lactating or 30 days post-partum
Source: ClinicalTrials.gov (NCT05678530). StuddyBuddy aggregates publicly available trial information.