The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT05678530
Recruitment Status : **RECRUITING NOW**
First Posted : January 10, 2023
Last Update Posted : January 10, 2023
Sponsor:
Information provided by (Responsible Party):
physIQ, Inc.
Go toÂ
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
Heart Failure Healthy
Go toÂ
Layout table for study information
Study Type :
Observational
Estimated 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 :
June 6, 2019
Estimated Primary Completion Date :
June 2023
Estimated Study Completion Date :
August 2023
Go toÂ
Healthy
Standard of Care
Go toÂ
Primary Outcome Measures :
Collect development and validation data for a VO2Max (eVO2Max) machine learning algorithm and to evaluate the performance of the algorithm. [ Time Frame: 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).
Go toÂ
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Layout table for eligibility information
Ages Eligible for Study: Â
18 Years and older  (Adult, Older Adult)
Sexes Eligible for Study: Â
All
Accepts Healthy Volunteers: Â
Yes
Sampling Method: Â
Probability Sample
Healthy Group: One cohort of participants will be “normal” (healthy) participants who volunteer for CPET testing.
Standard of Care Group: The second cohort of patients will be those with any medical diagnosis that necessitates investigation of functional capacity through cardiopulmonary exercise testing (testing as part of standard of care).
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
Go toÂ
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05678530
Layout table for location information
physIQ
Chicago, Illinois, United States, 60606
University of Illinois Hospital & Health Sciences System
Chicago, Illinois, United States, 60608
Contact: Dr. Cemal Ozemek   312-355-3996   ozemek@uic.edu  Â
Principal Investigator: Cemal Ozemek, PhD Â Â Â Â Â Â
Advocate Aurora Health Institute
Oakbrook Terrace, Illinois, United States, 60181
physIQ, Inc.
Layout table for investigator information
Principal Investigator:
Steve Steinhubl, MD
physIQ, Inc.
Go toÂ
Layout table for additonal information
Responsible Party:
physIQ, Inc.
ClinicalTrials.gov Identifier:
NCT05678530 Â Â
Other Study ID Numbers:
CTP-020
First Posted:
January 10, 2023 Â Â Key Record Dates
Last Update Posted:
January 10, 2023
Last Verified:
January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
No
Layout table for additional information
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart FailureHeart DiseasesCardiovascular Diseases
Source: View full study details on ClinicalTrials.gov
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
