Observational, Non-Interventional Study Supporting Validation of eVO2peak Using Results in Patients Receiving Standard of Care Cardiopulmonary Exercise Tests (CPET)

ClinicalTrials.gov ID: NCT05678530

Public ClinicalTrials.gov record NCT05678530. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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Official title

An Observational, Non-Interventional Study Supporting Validation of eVO2peak Using Results in Patients Receiving Standard of Care Cardiopulmonary Exercise Tests (CPET)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT05678530
Recruitment status: Recruiting
Study type: Observational
Phase: Not listed
Lead sponsor: Prolaio; Industry
Enrollment: 2,000 participants

Conditions and interventions

Conditions

Cardiopulmonary

Interventions

Not listed

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Jun 6, 2019 (Actual)
Primary completion: Dec 31, 2027 (Estimated)
Completion: Dec 31, 2027 (Estimated)
Last update posted: Sep 9, 2026

2019 – 2027

United States locations

U.S. sites: 15
U.S. states: 8
U.S. cities: 14

Facility	City	State	ZIP	Site status
Mayo Clinic Arizona	Scottsdale	Arizona	85259	Recruiting
VA Palo Alto Healthcare System	Palo Alto	California	94304	Recruiting
University of California San Francisco	San Francisco	California	94143	Recruiting
The Lundquist Institute	Torrance	California	90502	Recruiting
Nemours Cardiac Center	Wilmington	Delaware	19803	Recruiting
Memorial Healthcare System, Office of Human Research	Hollywood	Florida	33021	Recruiting
Mayo Clinic Florida	Jacksonville	Florida	32224	Recruiting
New Generation of Medical Research	Naples	Florida	34116	Completed
physIQ	Chicago	Illinois	60606	Completed
University of Illinois Hospital & Health Sciences System	Chicago	Illinois	60608	Completed
Advocate Aurora Health Institute	Oakbrook Terrace	Illinois	60181	Completed
Mayo Clinic	Rochester	Minnesota	55905	Recruiting
Baylor Scott & White Research Institute	Dallas	Texas	75246	Recruiting
Baylor Scott & White The Heart Hospital - Plano	Plano	Texas	75093	Recruiting
Intermountain Medical Center	Murray	Utah	84107	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT05678530, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Sep 9, 2026 · Synced Oct 17, 2026

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT05678530 live on ClinicalTrials.gov.

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