Recruiting

Observational Study

Sponsor:

Prolaio

Code:

NCT05678530

Conditions

Cardiopulmonary

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Study Details

Brief 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.

Conditions

Cardiopulmonary

Study ID

NCT05678530

Start date

Jun 6, 2019

Status verified date

Dec, 2025

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 palliated) with the following exception:

• Biventricular physiology without severe valvar dysfunction (e.g. free pulmonary insufficiency) at the discretion of the investigator.
5. Any history of allergy to adhesive
6. Any cognitive or physical limitations that, in the opinion of the investigator, limits the participant's ability to fully follow study procedures and/or reach a respiratory exchange ratio of 1.0.

Study Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

Healthy

Healthy Subjects who undergo the CPET

Standard of Care

Standard of Care subjects who undergo the CPET as part of routine Standard of Care

Primary outcome measure

  • Collect development and validation data for a VO2Max (eVO2Max) machine learning algorithm and to evaluate the performance of the algorithm. [ Time Frame: March 2025 ]

Central Contacts and Locations

Central contacts

Clinical Trials at Prolaio

855-869-9054hello@prolaio.com

Locations

Mayo Clinic Arizona

Recruiting

Scottsdale, Arizona, United States, 85259

Contacts

Principal Investigator:

Courtney Wheatley-Guy, PhD

VA Palo Alto Healthcare System

Recruiting

Palo Alto, California, United States, 94304

Contacts

Clinical Research Coordinator

650-493-5000jianfu1981@gmail.com

Principal Investigator:

Jonathan Myers, PhD

University of California San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

Clinical Research Coordinator

415-476-2060Jonathan.Thomas2@ucsf.edu

Principal Investigator:

Theodore Abraham, MD

The Lundquist Institute

Recruiting

Torrance, California, United States, 90502

Contacts

Clinical Trial Project Manager

310-222-5297ldiaz@lundquist.org

Principal Investigator:

William Stringer, MD

Nemours Cardiac Center

Recruiting

Wilmington, Delaware, United States, 19803

Contacts

Principal Investigator:

Takeshi Tsuda, MD

Memorial Healthcare System, Office of Human Research

Recruiting

Hollywood, Florida, United States, 33021

Contacts

Clinical Research Coordinator

954-265-1849PamShaw@mhs.net

Principal Investigator:

Iani Patsias, MD

Mayo Clinic Florida

Recruiting

Jacksonville, Florida, United States, 32224

Contacts

Clinical Research Coordinator

(513) 313-7710carlisle.ashley@mayo.edu

Principal Investigator:

Bryan J. Taylor, PhD

New Generation of Medical Research

Recruiting

Naples, Florida, United States, 34116

Contacts

Clinical Research Coordinator

239-331-4820nellym@ngmresearch.com

Principal Investigator:

Daniel Morales, MD

University of Illinois Hospital & Health Sciences System

Recruiting

Chicago, Illinois, United States, 60608

Contacts

Principal Investigator:

Cemal Ozemek, PhD

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Principal Investigator:

Thomas P. Olson, PhD

Baylor Scott & White Research Institute

Recruiting

Dallas, Texas, United States, 75246

Contacts

Research Enrollment Analyst

(214) 818-7621Erin.Lee@bswhealth.org

Principal Investigator:

Mark Millard, MD

Baylor Scott & White The Heart Hospital - Plano

Recruiting

Plano, Texas, United States, 75093

Contacts

Supervisor Clinical Research

469-814-3524shelby.mccoy@bswhealth.org

Principal Investigator:

Aasim M. Afzal, MD

Intermountain Medical Center

Recruiting

Murray, Utah, United States, 84107

Contacts

Project Coordinator, Outpatient Pulmonary Research

801-507-4800Stan.Pies@imail.org

Principal Investigator:

Matthew J. Hegewald, MD

Eastern Health Cardiac Rehabilitation

Recruiting

St. John's, Newfoundland and Labrador, Canada, A1N3J5

Contacts

Clinical Research Coordinator

709-777-7531Sarah.Anthony@easternhealth.ca

Principal Investigator:

Liam Kelly, PhD

More Information

Sponsor

Prolaio

Last update posted

Dec 30, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Prolaio on 2025-12-30.