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NCT05678530 · ClinicalTrials.gov registry record
Observational, Non-Interventional Study Supporting Validation of VO2Max Estimation Methods Using Results in Patients Receiving Standard of Care Cardiopulmonary Exercise Tests (CPET)
A clinical trial of Cardiopulmonary, sponsored by Prolaio.
- Recruiting
- Registry status
- 1,000
- Enrollment target
- 16
- Study locations
NCT05678530: Recruiting study of Cardiopulmonary, sponsored by Prolaio.
NCT05678530 is a study of Cardiopulmonary that is actively recruiting participants, run by Prolaio. The registered enrollment target is 1,000 participants. The trial reports 16 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05678530, a study of Cardiopulmonary, is actively recruiting participants, sponsored by Prolaio.
- RECRUITING
- Registry status
- 1,000 participants
- Enrollment target
- 16
- Study locations
Study 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.
Primary Outcome
Develop an Estimated VO2Max (eVO2Max) algorithm which will estimate a participant's VO2Max value using data collected from physiological wearable biosensors (ECG \& Activity).
Conditions Studied
Study Locations (16)
California
- VA Palo Alto Healthcare System - Palo Alto
- University of California San Francisco - San Francisco
- The Lundquist Institute - Torrance
Florida
- Memorial Healthcare System, Office of Human Research - Hollywood
- Mayo Clinic Florida - Jacksonville
- New Generation of Medical Research - Naples
Illinois
- physIQ - Chicago
- University of Illinois Hospital & Health Sciences System - Chicago
- Advocate Aurora Health Institute - Oakbrook Terrace
Texas
- Baylor Scott & White Research Institute - Dallas
- Baylor Scott & White The Heart Hospital - Plano - Plano
Arizona
- Mayo Clinic Arizona - Scottsdale
Delaware
- Nemours Cardiac Center - Wilmington
Minnesota
- Mayo Clinic - Rochester
Utah
- Intermountain Medical Center - Murray
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,000 participants |
| Start Date | 2019-06-06 |
| Est. Completion | 2027-03-31 |
What NCT05678530 shows while recruiting
NCT05678530 is an observational study that tracks outcomes without assigning an intervention. Its 1,000 participants enrollment target places it among the larger protocols in the corpus.
The record links to 1 condition, with Cardiopulmonary appearing as the primary indexed condition, and to 0 interventions.
NCT05678530 lists 16 locations in 9 states (California, Florida, Illinois).
Frequently Asked Questions
What is clinical trial NCT05678530 about?
NCT05678530 is a clinical study titled "Observational, Non-Interventional Study Supporting Validation of VO2Max Estimation Methods Using Results in Patients Receiving Standard of Care Cardiopulmonary Exercise Tests (CPET)". 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 participan...
What is the current status of trial NCT05678530?
This trial is currently recruiting. The enrollment target is 1,000 participants. The study started on 2019-06-06. Estimated completion is 2027-03-31.
What conditions does trial NCT05678530 study?
This clinical trial studies the following conditions: Cardiopulmonary.
Who is sponsoring clinical trial NCT05678530?
This trial is sponsored by Prolaio, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05678530 being conducted?
This trial has 16 study locations across Arizona, California, Delaware, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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