Observational, Non-Interventional Study Supporting Validation of VO2Max Estimation Methods
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
| Condition(s) | Cardiopulmonary |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| 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 1000 participants will be enrolled including: (Normal) 100 participants, self-reported healthy male and female participants aged 18 to 80 and (Standard of Care) 900 participants. |
| Who can participate | Inclusion Criteria: 1. Willing and able to comply with protocol procedures and available for the duration of the study. 2. Willing to sign and date informed consent document for study participation. 3. Participant is undergoing the Cardiopulmonary Exercise Test (CPET) as Standard of Care Exclusion Criteria: 1. Participant is pregnant, lactating or ≤30 days post-partum. 2. Participant has limited or no intrinsic sinus node function (i.e. chronic atrial pacing). • If participant has an indwelling cardiac device and programming cannot be sufficiently ascertained to assure sinus node competence and lack of atrial pacing, the patient should be excluded. 3. Barostim (™) or similar noncardiac electrical pulse generating device in situ. 4. Complex congenital heart disease (even repaired or palliat |
| Ages | 18 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | Prolaio |
| Locations | Scottsdale, Arizona, United States; Palo Alto, California, United States; San Francisco, California, United States; Torrance, California, United States; Wilmington, Delaware, United States; Hollywood, Florida, United States (+10 more sites) |
| Start date | 2019-06-06 |
| NCT ID | NCT05678530 |
| Official listing | https://clinicaltrials.gov/study/NCT05678530 |