Clinical trials: Validation Studies
Keratoconjunctivitis Sicca
TearLab Core Validation Study to Establish Referent Values for Dry Eye Disease
This is a prospective, observational case series to determine the clinical utility of tear osmolarity and other commonly used objective tests to diagnose dry eye disease, as well as to establish referent values for objective…
- Trial name
- CVS (NCT00848198)
- Where
- 10 sites in United States, France and 3 more
- Volunteers
- 314 people, healthy volunteers welcome
- Sponsor
- TearLab Corporation
Drug Mechanism, Healthy
Detection of Paracetamol Concentration in Blood-, Saline- and Urine Samples - a Validation Study for a Novel Technique
The main objective is to assess whether a novel electrochemical tool is reliable in detecting concentration of paracetamol in fingerprick- , saline-, urine-, and serum samples. We will recruit 12 healthy volunteers aged 18-45.
- Trial name
- NCT04690673
- Testing
- Paracetamol, Paracetamol concentration measurements and lipidomic assessment
- Where
- Finland
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Johanna Kujala
Sleep Apnea
A Validation Study of the NightOwl PAT-based Home Sleep Apnea Test
The objective of this study is to evaluate the performance of a miniaturized sleep apnea test, called NightOwl. The system consists of a sensor placed on the fingertip and a cloud-based analytics software.
- Trial name
- NCT04191668
- Testing
- NightOwl
- Where
- 3 sites in United States
- Volunteers
- 106 people, healthy volunteers welcome
- Sponsor
- Ectosense NV
Nutrition Assessment
Validity of an AI-based Program to Identify Foods and Estimate Food Portion Size
The purpose of this study is to test the accuracy of the Nutrition Artificial Intelligence in the Openfit app during meals in a controlled laboratory setting
- Trial name
- PortionSizeAI (NCT05343585)
- Testing
- PortionSize AI
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Pennington Biomedical Research Center
Healthy
A Study to Validate Treadmill Parameters
The purpose of this study is to evaluate the accuracy with which a microprocessor-controlled treadmill delivers controlled postural disturbances.
- Trial name
- NCT05333263
- Testing
- Treadmetrix
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Mayo Clinic
Myopia, Hyperopia
Comparing Low-cost Handheld Autorefractors - a Practical Approach to Measuring Refraction in Low Resource Settings
Study compares four portable vision measurement and eye-imaging technologies in terms of accuracy and time and ease of use with older adult (ages 40-100) participants in a developing-country setting (India).
- Trial name
- NCT03456245
- Testing
- Vision device validation
- Volunteers
- 205 people, healthy volunteers welcome
- Sponsor
- Harvard School of Public Health (HSPH)
Measure Accuracy of Respiratory Rate
Respiratory Rate Validation Study
The purpose of this study is to conduct a Respiratory Rate accuracy validation on pediatrics population comparing the Gabi SmartCare Gabi Band to the Reference, an FDA cleared End Tidal Carbon Dioxide monitor (GE Datex- Ohmeda)…
- Trial name
- NCT05856422
- Testing
- Respiratory rate measure based on PPG
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Gabi SmartCare
Device Validation of In-vivo Performance
An In Vivo 24-Hour Recovery Study of Whole Blood by the Reveos System
This is an in vivo 24-hour recovery study of leukoreduced red blood cells (RBCs) after automated separation of whole blood by the Reveos Automated Blood Processing System and storage for 42 days.
- Trial name
- NCT05239455
- Testing
- Reveos® Automated Blood Processing System
- Where
- 2 sites in United States
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Terumo BCT
Cardiac Arrhythmia
Validation Study: Extended Wear Performance of the Zio Monitor - SHASTA II
This trial assesses the wear performance of the Zio monitor, a long-term continuous ambulatory patch ECG monitor, in a representative population by evaluating (1) the wear duration (up to 30 days) of the device, (2) the…
- Trial name
- NCT07205367
- Testing
- Zio Monitor
- Where
- 2 sites in United States
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- iRhythm Technologies, Inc.
Opioid Use Disorder
Assessment of Methadone and Buprenorphine in Interstitial Fluid
The purpose of this research is to determine if common medications for opioid use disorder (i.e., buprenorphine/naloxone, buprenorphine, methadone) and their metabolites (norbuprenorphine [a metabolite of buprenorphine]…
- Trial name
- NCT05546229
- Testing
- Microneedle based interstitial fluid collection
- Where
- United States
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- Cari Health Inc.
Validation Studies
d13C Added Sugar Intake Biomarker: Determining Validity in Children
Added sugars (AS) constitute a significant source (~ 16%) of the total daily calories consumed by youth. The role of AS in health is contentious, and the reliance on self-reported dietary data is an often-cited flaw in existing…
- Trial name
- NCT02455388
- Testing
- High added sugar diet, Low added sugar diet
- Where
- United States
- Volunteers
- 370 people, healthy volunteers welcome
- Sponsor
- Virginia Polytechnic Institute and State University
Cardiopulmonary Disease
Respiration Validation for CPM Device
This study is designed to be a clinical validation study to ready the CPM System for FDA 510(k) submission. This study will be conducted as a prospective non-randomized.
- Trial name
- NCT05445492
- Testing
- CPM Device
- Where
- United States
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Analog Device, Inc.
Oxygen Deficiency
Validation of the O3 Regional Somatic Tissue Oxygenation Monitor
Testing the absolute accuracy of the Masimo O3 regional oximeter in reading somatic tissue oxygenation in healthy volunteers under controlled hypoxia.
- Trial name
- NCT04584788
- Testing
- Masimo O3 Regional Oximeter
- Where
- Netherlands
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Masimo Corporation
Dementia, Alzheimer Disease
The Brain Health Study: A Pragmatic, Patient-Centered Trial
The eRADAR Brain Health Study seeks to refine and test a novel, low-cost strategy for increasing dementia detection within primary care.
- Trial name
- NCT05356702
- Testing
- Brain Health Assessment
- Where
- 5 sites in United States
- Volunteers
- 3,417 people, healthy volunteers welcome
- Sponsor
- Kaiser Permanente
Obstructive Sleep Apnea
Belun Ring Validation Study for Assessment of Obstructive Sleep Apnea
This study aims to determine the overall accuracy, sensitivity, and specificity of the Belun Ring device in evaluating obstructive sleep apnea by comparing the device to the attended overnight in-lab polysomnography which is the…
- Trial name
- NCT03997916
- Testing
- Belun Ring, PSG
- Where
- 2 sites in United States
- Volunteers
- 113 people, healthy volunteers welcome
- Sponsor
- University Hospitals Cleveland Medical Center
Body Composition
Hydration Factor Study for the Stayhealthy BC3
This was a pilot study to validate the BC3 hydration factor which will be important for determining how well this value represents hydration status compared to assessment of total body water by D20.
- Trial name
- NCT01209936
- Testing
- D2O
- Where
- United States
- Volunteers
- 360 people, healthy volunteers welcome
- Sponsor
- University of Southern California
Dyspepsia
Carbon-13 (13C)-Spirulina Platensis Gastric Emptying Breath Test (GEBT)
The purpose of this study is to compare stomach emptying using 13C-Spirulina platensis breath test and scintigraphy in healthy subjects and subjects with dyspepsia.
- Trial name
- NCT01248221
- Testing
- [13C]-Spirulina platensis and 99mTc sulfur colloid
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Mayo Clinic
Refractive Errors, Astigmatism
Study of a Hand-held Device Plus Mobile App Versus Standard Eye Care Devices in Measuring Refractive Error of the Eye
Single-center, open-label, prospective study in healthy volunteers desiring refraction for correction of visual acuity to compare a handheld device supported by a mobile application with the phoropter and autorefractor.
- Trial name
- NCT03929588
- Testing
- Hand-held device supported by a mobile application, Phoropter, Autorefractor
- Where
- United States
- Volunteers
- 230 people, healthy volunteers welcome
- Sponsor
- EyeQue Corp.
Tobacco Dependence
UW Withdraw From Tobacco Study
It is of considerable scientific and clinical importance to assess tobacco withdrawal accurately since withdrawal severity is highly determinant of smoking cessation success.
- Trial name
- NCT04969198
- Testing
- Combination nicotine replacement therapy (Nicotine patch + nicotine mini-lozenge)
- Where
- United States
- Volunteers
- 232 people, healthy volunteers welcome
- Sponsor
- University of Wisconsin, Madison
Cardiopulmonary Disease
Clinical Validation Study for Noninvasive Cardiopulmonary Management Device
The ADI At-Home CPM (Cardiopulmonary Management) System is a non-invasive device that measures and trends a variety of biological parameters.
- Trial name
- NCT04865640
- Testing
- Noninterventional and noninvasive
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Analog Device, Inc.