Loading clinical trials...

COMPLETEDNA

VL-3 Training Study

PROSPECTIVE STUDY EVALUATING THE VITAL LABS DIGITAL BLOOD PRESSURE MONITOR (VLDBPM)

NCT05356754•Riva Health

Summary

The primary endpoints for this study are mean and standard deviation error measurements for the VLDBPM versus manual auscultation.

Detailed Description

This is a prospective, controlled, single-arm clinical evaluation. Five hundred thirty-two (532) subjects are planned to be evaluated. Each subject's blood pressure will be measured using the VLDBPM and manual auscultation. Each subject will be observed while undergoing a series of blood pressure perturbation challenges. Means measurement differences from the test sensor and the reference auscultation measurements will be used to validate the accuracy of the VDBPM software system. Screening data will be reviewed to determine subject eligibility. Subjects who meet all inclusion criteria and none of the exclusion criteria will be entered into the study. Total duration of subject participation will be 1 to 1.5 hours. Total duration of the study is expected to be 6 months. Following medical history and patient eligibility assessments, eligible patients will be offered participation in the study. Once subjects are consented/enrolled, measurements will be performed in accordance with Data Collection Procedure section below.

Eligibility

Age

18 - 85 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Male or female ≥18 and ≤ 85 years of age at the Baseline Visit.
•Written informed consent obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.
•A minimum of 30% of the data will be derived from male subjects; and a minimum of 30% of the data will be derived from female subjects.
•A minimum of 50 participants will have dark skin types, as defined by the Fitzpatrick Skin Type classification V or VI.
•Also, at least 10 participants should exhibit finger calluses, found typically on individuals who play stringed instruments frequently.

Exclusion Criteria

•1\. Pregnant and/or breastfeeding. 2. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
•3\. Are unable or unwilling to undergo all assessments associated with the study.
•4\. Have a history of poor quality or difficulty performing auscultation measurements.
•5\. Subjects shall be excluded if the Korotkoff sound \[fifth phase (K5)\] is not audible 6. Subjects with vascular implants in the arm of measurement, such as those used for dialysis 7. Subject suffering from a medical condition prohibiting blood flow occlusion in either arms.
•8\. Pre-existing conditions that may interfere with the accuracy or interpretation of auscultatory readings, such as aortic coarctation, arterial-venous malformation, occlusive arterial disease, or the presence of an antecubital bruit.
•9\. Subjects who have known allergies to nitroglycerin (for subjects undergoing the nitroglycerin challenge).
•10\. Subjects who have taken short acting nitroglycerin within 4 hours of the scheduled study. Such studies will be deferred for at least 4 hours.
•11\. Subjects who have taken long acting nitroglycerin within 8 hours of the scheduled study. Such studies will be deferred for at least 8 hours.
•12\. Subjects with pericardial tamponade, restrictive cardiomyopathy, or constrictive pericarditis, or cardiac output is dependent upon venous return

Locations (3)

University of California San Francisco

San Francisco, California, United States

Diablo Clinical Research

Walnut Creek, California, United States

University of Colorado Hospital

Aurora, Colorado, United States

Key Dates

Start Date

July 13, 2020

Primary Completion Date

November 8, 2021

Completion Date

November 8, 2021

Last Updated

May 2, 2022

Enrollment

343

ACTUAL participants

Conditions

HypertensionBlood Pressure

Interventions

The Vital Labs Digital Blood Pressure Monitor

DEVICE

Natural History of Noncirrhotic Portal Hypertension

NCT02417740

Cystic FibrosisImmunologic Deficiency Syndrome+3 more

View study

RECRUITINGNA

Transcutaneous Auricular Vagus Nerve Stimulation and Spirometry: Sham-Controlled Randomized Trial

NCT07482930

Vagus Nerve StimulationsSpirometry+3 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 2, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

VL-3 Training Study

Inclusion Criteria

Exclusion Criteria

Natural History of Noncirrhotic Portal Hypertension

Transcutaneous Auricular Vagus Nerve Stimulation and Spirometry: Sham-Controlled Randomized Trial

A Study to Learn About the Study Medicine (Called PF-07868489) in People With Pulmonary Arterial Hypertension Who Have Previously Participated in a Clinical Study With PF-07868489

Homocysteine and Early Diastolic Dysfunction in Newly Diagnosed Hypertension

Mobile Cued Adherence Therapy (mCAT) for Blood Pressure Medication

Penn Medicine Healthy Heart