Clinical trials: Accuracy
Insomnia, Secondary, Sleep Disturbance
Robustness and Usability of the Dreem 3 System for at Home Sleep Monitoring in an Insomnia Population.
There is an unmet medical need for monitoring sleep for multiple nights in a patient's home, without the inconvenience of traveling and staying overnight in a medical center, and without the need for a technician to set up a…
- Conditions
- Insomnia, Secondary, Sleep Disturbance, Sleep, Sleep Initiation and Maintenance Disorders
- Trial name
- NCT05611099
- Testing
- Dreem 3 System vs WatchPAT One, Usability Questionnaire
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Dreem
Hypoxia
Determination of SpO2 and PR Accuracy Specifications at Rest (71Ag_Vital-0031)
The aim of this study is to determine the accuracy of devices called pulse oximeters, which measure blood oxygen by shining light through fingers, ears or other skin, without requiring blood sampling.
- Trial name
- NCT05297500
- Testing
- Pulse oximeter
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Nihon Kohden
Diabetes Mellitus
Clinical Experimental Study to Investigate Specific Features of ClampArt®
A single centre, clinical experimental study. Every subject will undergo clamp experiments, where a clamp device (ClampArt®) measures and controls the blood glucose concentration after administration of marketed insulin products.
- Trial name
- NCT01906970
- Testing
- ClampArt
- Where
- Germany
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Profil Institut für Stoffwechselforschung GmbH
Non-invasive Blood Pressure
Non-Invasive Blood Pressure Monitor Accuracy in Neonatal Subjects
This study is being conducted to validate the accuracy of non-invasive blood pressure (NIBP) measurement technology from Mortara Instrument, Inc. (Milwaukee, Wisconsin, USA) and Zoe Medical, Inc.
- Trial name
- NCT02642198
- Testing
- Surveyor S12 and S19 patient monitor
- Where
- 2 sites in Italy
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Mortara Instrument
Healthy
Accuracy of Noninvasive Pulse Oximeter Sensor (LNCS DBI)
In this study, the level of oxygen within the blood will be reduced in a controlled manner by reducing the percentage of oxygen the study volunteer breathes.
- Trial name
- NCT03124979
- Testing
- LNCS DBI Sensor
- Where
- United States
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Masimo Corporation
Pulse Oximetry
SpO2 Accuracy In Vivo Testing for Neonates & Infants
The purpose of this clinical study is to validate the oxygen saturation (SpO2) accuracy of various pulse oximetry systems and sensors (new designs and/or reprocessed) during non-motion conditions as compared to arterial blood…
- Trial name
- NCT03843489
- Testing
- MEDLINE RENEWAL PULSE OXIMETRY SENSORS, Reference CO-oximetry sensor
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Medline Industries
Hypoxia
Oxitone Sp02 Hypoxia Test Versus Reference Pulse Oximetry
The purpose of this study is to conduct a SpO2 hypoxia evaluation of the Oxitone Medical Oxitone 1000 pulse oximeter. The Oxitone 1000 pulse oximeter will be evaluated during non-motion conditions over the range of 70-100% SpO2…
- Trial name
- NCT02870179
- Testing
- Pulse Oximeter
- Where
- United States
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- Oxitone Medical Ltd.
Anoxia
Accuracy Validation of the Cadwell Pulse Oximetry System
The purpose of this study is to evaluate the SpO2 accuracy and performance of the Cadwell Pulse Oximetry system during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by…
- Trial name
- NCT02842476
- Testing
- Disposable Sensor, Reusable Sensor, Control Pulse Oximetry
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- Cadwell Industries, Inc.
Allergy, Hypersensitivity, Immediate
Head-to-Head Comparison Study Between Different FDA Registered Allergy Skin Test Applicators
This clinical study, titled "Head-to-Head Comparison Study between Different FDA Registered Allergy Skin Test Applicators," aims to compare the reliability and clinical performance of three skin prick test (SPT) devices…
- Conditions
- Allergy, Hypersensitivity, Immediate, Ig-E Mediated Food
- Trial name
- NCT07400718
- Testing
- AllerTest-10 Multi-Head Skin Test Device, Skintestor OMNI Multi-Head Skin Test Device, Multi-Test II Multi-Head Skin Test Device
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- QHSLab, Inc.
Hypoxia
SpO2 Accuracy Validation of Pulse Oximetry Systems During Motion and Non-Motion Conditions
Study to evaluate the %SpO2 accuracy performance of the Nonin Medical pulse oximetry systems.
- Trial name
- NCT02475668
- Testing
- Pulse oximeter
- Where
- United States
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Nonin Medical, Inc
Accuracy of Respiration Rate Measurement
Reassure Device: Measurement Accuracy of Continuous Respiration Rate
The aim of the trial is to prove that the Reassure10.5 GHz sensor is equivalent in performance to the SomnoScreen Plus RC in indicating the breathing rate of adult subjects over a number of hours when the subjects are lying still…
- Trial name
- NCT02740478
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- ResMed
Tuberculosis (TB)
QuantiFERON Access Clinical Performance Study Protocol
Approximately 225 samples, obtained from participants with varying risk factors for TB infection and disease, will be tested using the QFT Access Kit and the comparator device QFT-Plus.
- Trial name
- NCT04243031
- Testing
- QFT Access
- Volunteers
- healthy volunteers welcome
- Sponsor
- QIAGEN Gaithersburg, Inc
Oximetry
EmbracePlus SpO2 Accuracy Validation
The aim of this study is to test the accuracy of EmbracePlus computed SpO2 during mild, moderate and severe hypoxia (a lower-than-normal concentration of oxygen in arterial blood); ie, a range of arterial HbO2 saturations from…
- Trial name
- NCT04964609
- Testing
- EmbracePlus
- Where
- United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Empatica, Inc.
Healthy, Febrile Illness
Prospective Study to Validate the Clinical Accuracy of Norbert Device to Measure Body Temperature
The study will evaluate the clinical bias and clinical repeatability of measuring body temperature using the Norbert Device (ND).
- Trial name
- NCT05640310
- Testing
- Norbert Device
- Volunteers
- healthy volunteers welcome
- Sponsor
- Norbert Health
Influenza -Like Illness, Influenza A
Home Testing of Respiratory Illness
The main goal of this research study is to use data from activity trackers (such as Fitbits), lab tests, and surveys to see if activity, sleep, and heart rate data can tell the difference between when someone has a respiratory…
- Conditions
- Influenza -Like Illness, Influenza A, Influenza Type B, Respiratory Viral Infection
- Trial name
- NCT04245800
- Where
- United States
- Volunteers
- 5,233 people, healthy volunteers welcome
- Sponsor
- Evidation Health
Coronary Artery Disease
Evaluation of Diagnostic Accuracy of MCG(Magnetocardiography) Scan in Suspected Coronary Artery Disease
This multicenter clinical trial is designed to evaluate the diagnostic accuracy of MCG scan in detecting significant CAD compared to the reference standard CAG.
- Trial name
- EDAM-CAD (NCT05825911)
- Testing
- Rest/Stress MCG scan, Rest MCG scan
- Where
- 2 sites in South Korea
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- AMCG
Surgery, Healthy
Accuracy of Noninvasive Pulse Oximeter Measurement of Hemoglobin for Rainbow DCI Sensor
In this study, the concentration of hemoglobin within the subject's blood is affected by fluid status changes. The fluid status is affected by fluid loss during surgery for hospitalized study subjects or controlled administration…
- Trial name
- NCT03124901
- Testing
- DCI pulse oximeter sensor
- Where
- 2 sites in United States
- Volunteers
- 147 people, healthy volunteers welcome
- Sponsor
- Masimo Corporation
Hypoxia
Polso SpO2 Accuracy Validation Study
The purpose of this study is to validate the oxygen saturation (SpO2) accuracy of the Polso Monitoring System during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by…
- Trial name
- NCT03735329
- Testing
- Diagnostic test of SPO2
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- ChroniSense Medical Ltd.
Term Labour
Accuracy and Reliability of Novii: Fetal Heart Rate (FHR), Maternal Heart Rate (MHR) and Uterine Contraction (UA) Compared With Doppler, Scalp Fetal Scalp Electrode (FSE), Tocodynamometer (TOCO) and Intra Uterine Pressure Catheter (IUPC)
Accuracy and Reliability of the Novii device (fetal heart rate, maternal heart rate and uterine activity) compared with Food and Drug Administration (FDA) approved techniques
- Trial name
- NCT03409146
- Testing
- Monica Novii Wireless Patch System
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- GE Healthcare
Hypoxia
Induced Hypoxia Study for Validation of SpO2 Accuracy
Validate Non-Motion SpO2 Accuracy from 70%-100% of various pulse oximeter/ sensor combinations and various OEM pulse oximeter modules and sensor combinations during induced hypoxia (desaturation).
- Trial name
- NCT00788983
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Nonin Medical, Inc