Estimated VO2Max Validation

Sponsor

physIQ, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05678530

Collaborator

(none)

400

Enrollment

Locations

49.8

Anticipated Duration (Months)

133.3

Patients Per Site

2.7

Patients Per Site Per Month

Study Details

Study Description

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 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

Condition or Disease	Intervention/Treatment	Phase
Heart Failure Healthy

Study Design

Study Type:

Observational

Anticipated Enrollment :

400 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Validation of VO2Max Estimations Using Healthy and Standard of Care Participants

Actual Study Start Date :

Jun 6, 2019

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Aug 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Healthy
Standard of Care

Outcome Measures

Primary Outcome Measures

Collect development and validation data for a VO2Max (eVO2Max) machine learning algorithm and to evaluate the performance of the algorithm. [August, 2023]
Develop an Estimated VO2Max (eVO2Max) algorithm which will estimate a participant's VO2Max value using data collected from physiological wearable biosensors (ECG & Activity). This estimation algorithm will be developed using a portion of the collected data (physiological biosignals + CPET) from healthy participants and a portion of data from a separate cohort with a clinical indication requiring functional capacity evaluation (called the Standard of Care Cohort).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Has a clinical indication for investigation of functional capacity through cardiopulmonary exercise testing
Willing and able to comply with protocol procedures
Willing to sign and date informed consent document for study participation

Exclusion 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 1.0
Participant has an allergy to the adhesive used on the VitalPatch
Participant is pregnant, lactating or 30 days post-partum

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	physIQ	Chicago	Illinois	United States	60606
2	University of Illinois Hospital & Health Sciences System	Chicago	Illinois	United States	60608
3	Advocate Aurora Health Institute	Oakbrook Terrace	Illinois	United States	60181

Sponsors and Collaborators

physIQ, Inc.

Investigators

Principal Investigator: Steve Steinhubl, MD, physIQ, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

physIQ, Inc.

ClinicalTrials.gov Identifier:

NCT05678530

Other Study ID Numbers:

CTP-020

First Posted:

Jan 10, 2023

Last Update Posted:

Jan 10, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Heart Failure

Study Results

No Results Posted as of Jan 10, 2023