Treatment Trials

54 Clinical Trials for Various Conditions

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RECRUITING
Effect of ANNE One-Wellue Device Array Use on Staff Bedside Vital Sign Measurement Activity
Description

Randomized controlled trial of a time motion study of time spent obtaining and charting vital signs for inpatients, comparing use of a wireless Bluetooth vital sign array as intervention versus routine vital sign obtainment activity on a general medical floor.

RECRUITING
Vital Signs Reduction Study
Description

Overnight vital signs are typically done every four hours on pediatric acute care units, despite limited evidence supporting the efficacy of this practice. Additionally, vital signs are often ordered and collected without considering the patient's clinical status or the potential impact that they may have on sleep. The purpose of this study is to understand the effect of forgone overnight vital signs on sleep quality and duration among children hospitalized in medical-surgical units, compared with children who receive standard of care vital signs.

Conditions
COMPLETED
Cubii Vital Sign and Range of Motion Study
Description

The purpose of this study is to evaluate the effect of a seated compact elliptical on vital signs and range of motion (of knees and ankles) following thirty minutes of activity.

RECRUITING
Expanding Access to Care Through Telemedical Support for Vital Sign Monitoring in High-risk Patients With Cancer
Description

A randomized trial of remote blood pressure monitoring, compared to usual care, in patients receiving bevacizumab to determine whether remote blood pressure monitoring improves the collection of blood pressure data, identification and management of clinically significant hypertension, and patient satisfaction.

Conditions
RECRUITING
Evaluation of an Investigational Wearable Vital Signs Monitoring Device in Healthy Infants
Description

The primary objective of this study is to evaluate the feasibility of the use of an investigational wearable vital sign monitoring device in infants.

NOT_YET_RECRUITING
Novel Sepsis Sub-phenotypes Based on Trajectories of Vital Signs
Description

Sepsis is a dysregulated host response to infection resulting in organ dysfunction. Over the past three decades, more than 30 pharmacological therapies have been tested in \>100 clinical trials and have failed to show consistent benefit in the overall population of patients with sepsis. The one-size-fits-all approach has not worked. This has resulted in a shift in research towards identifying sepsis subphenotypes through unsupervised learning. The ultimate objective is to identify sepsis subphenotypes with different responses to therapies, which could provide a path towards the precision medicine approach to sepsis. The investigators have previously discovered sepsis subphenotypes in retrospective data using trajectories of vital signs in the first 8 hours of hospitalization. The team aims to prospectively classify adult hospitalized patients into these subphenotypes in a prospective, observational study. This will be done through the implementation of an electronic health record integrated application that will use vital signs from hospitalized patients to classify the patients into one of four subphenotypes. This study will continue until 1,200 patients with infection are classified into the sepsis subphenotypes. The classification of the patients is only performed to validate the association of the subphenotypes with clinical outcomes as was shown in retrospective studies. Physicians and providers treating the patients will not see the classification, and the algorithm classifying the patients will in no way affect the care of the patients. Further, all the data needed for the algorithm (vital signs from the first 8 hours) are standard of care, and enrollment in the prospective study does not require any additional data.

Conditions
TERMINATED
Feasibility of a New Ambulatory Multi-vital Signs Monitor
Description

The purpose of this research is evaluate vital signs (VS), which include non-invasive blood pressure, pulse rate, respiratory rate and Oxygen Saturation (SpO2) using a portable wrist monitoring device called a Caretaker. This device has been cleared by the Food and Drug Administration (FDA) for use and allows the study team to check vital signs in a participant's normal setting. Participation in this study will involve wearing this portable device at 2 different time points: 1. for up to 24 hours immediately during and after the participant's preoperative visit to obtain baseline vital signs during normal activity and during sleep and 2. after surgery up to 24 hours while participant recovers prior to discharge from the hospital

UNKNOWN
Performance Assessment Study VitalSigns Camera
Description

This Performance Assessment Study will focus on testing the performance of the VitalSigns Camera under various suboptimal use cases. The software makes it possible to measure the pulse rate (PR) and respiration rate (RR) without the device being in contact with the subject. The software delivers fast and accurate results (in less than one minute). Vital signs camera (VSC) product will be used via a demonstrator app on one of the smartphones during the study sessions (camera of the phone will be used by the VSC product). Devices will be provided by the researchers. The subject will be asked to perform a number of assignments with the software application. The study involves taking a number of measurements of the subject's PR using the VitalSigns Camera software application (which is installed on a smartphone or laptop). In this study only PR is measured and not RR as the latter parameter is not affected by the designed test cases. The total duration of the session will be approximately 1 hour. In total, approximately 30 healthy volunteers will participate in this study.

COMPLETED
Implementation of Digital Vital Sign Monitoring to Decrease Sleep Interruption and Enhance Recovery in Phase II of the PROmoting Sleep, Patient Engagement and Recovery (PROSPER) Project
Description

This phase II/III trial examines how a sleep enhancement intervention, including the use of wearable digital vital sign monitoring device (ViSi), affects the quality of life of cancer patients receiving acute care. Sleep enchancement interventions may improve the quality of life of patients with cancer due to fewer interruptions at night during hospital stays.

Conditions
COMPLETED
Monitoring Vital Signs With a Wireless Ingestible Device in Subjects Undergoing Polysomnography
Description

This Minimal Risk study is designed to evaluate the ability of the Celero ingestible Vitals Monitoring Pill (i.e., VM Pill) to measure respiration from within the gastrointestinal tract, in addition to performing an exploratory comparative analysis of data collected by the VM Pill and data collected from clinical monitoring sensors as part of polysomnography.

Conditions
RECRUITING
Real Time Vital Sign Assessment to Predict Neurological Decline After Traumatic Brain Injury
Description

This study will look to validate predictive algorithms developed in a previous study where we collected relevant data from trauma registry and after using advanced signal-processing and machine-learning, determined prediction scores regarding neuroworsening and other outcomes following traumatic brain injury.

ACTIVE_NOT_RECRUITING
Assessment of Remote Vital Signs for Telemedicine Applications
Description

The purpose of this study is to determine whether vital signs can be extracted from video. A secondary purpose is to create a database, including raw video, of "ground truth" physiological data on human subjects in order to test current and/or future approaches developed to extract vital signs from video. This research may have an immediate impact on not only the assessment of risk for COVID-19 but also may provide a significant technological enhancement to Johns Hopkins Medicine's telemedicine capabilities.

RECRUITING
Evaluating Wearable Smart Sensors for Continuous Measurement of Vital Signs in ICU Patients
Description

The purpose of this study is to develop biocompatible wireless electronic devices that will allow continuous, non-invasive hemodynamic and physiology measurements in the ICU.

Conditions
COMPLETED
Advanced Multimodal Wireless Vital Signs Monitoring for Patients With Asthma and Anaphylaxis
Description

The primary objective of this study is to assess the function and reliability of a non-invasive, skin-like electronic sensor. We hypothesize that this skin sensor will address an unmet need to wirelessly, noninvasively, and rapidly assess critical vital signs and other measures essential to healthcare monitoring for patients with asthma and anaphylaxis.

TERMINATED
Heart Failure Study to Evaluate Vital Signs and Overcome Low Use of Guideline-Directed Therapy by Remote Monitoring
Description

A study evaluating the impact of remotely collected data, measured using digital technologies, on the use of guideline-recommended heart failure therapy in adult participants with heart failure.

Conditions
UNKNOWN
Mobile Biosensor for Measuring Vital Signs in Healthcare and Home Settings
Description

This study will record vital signs (heart rate and blood oxygen levels) using a new cell phone integrated biosensor and compare it to routine measurements carried out in the clinics and hospital at UCSD. Cell phones will be given to a selected group of subjects for use at home and data collected.

Conditions
RECRUITING
Continuous Vital Sign Monitoring in Newborns
Description

This study evaluates the feasibility and usability of continuous wireless vital sign monitoring of well newborns during their birth hospitalization.

COMPLETED
CCU Wireless Vital Signs Monitoring
Description

This is a pilot study is to test a wireless, skin-sensor device against current technology in the CCU to monitor vitals

Conditions
COMPLETED
Standing Balance as the Fifth Vital Sign in Clinical Setting
Description

This 18-month prospective, observational study involving real world data will determine if the use of a standing scale that delivers a quantitative measure of standing balance along with weight (balance + weight) in place of a scale that only delivers weight (weight only) influences clinical decision making by health care practitioners in the ambulatory outpatient setting. Providers will be randomized to receive the balance+weight scale or weight-only scale for 9 months, then to crossover and receive the other for 9 months. The primary outcome measures are (1) providers' self-reported perceptions of whether the balance measurement influences their clinical decision making and (2) the rate of performing falls risk assessments or referring to a specialist for evaluation and treatment based on aggregate billing data. The secondary outcome measure is qualitative interviews with practitioners regarding their perceptions on the utility and barriers to using the device.

COMPLETED
De-escalating Vital Sign Checks
Description

The overall goals for this study are: 1) to develop a predictive model to identify patients who are stable enough to forego vital sign checks overnight, 2) incorporate this predictive model into the hospital electronic health record so physicians can view its output and use it to guide their decision-making around ordering reduced vital sign checks for select patients.

COMPLETED
Evaluating the Accuracy of an Integrated Vital Sign Measurement Platform
Description

Partners Connected Health will conduct a clinical validation study to evaluate the accuracy of measurement for each vital sign with the Vital Moto Mod platform, compared to appropriate reference devices used in the hospital setting. The study will recruit volunteers from the Partners Healthcare network of clinics and hospitals and the general public.

Conditions
COMPLETED
Pilot Clinical Evaluation of the RHEA Vital Sign Vigilance System in Hospital Patients
Description

This study compares both of the investigational device and reference device to the gold standard Patient Monitor of the accuracy of heart rate and respiratory rate monitoring. The primary variables for the analysis of heart rate (HR) and respiratory rate (RR) are each of the overall mean roots mean square difference (RMSD). Results of the investigational device and reference device compared with the patient monitor is evaluated to see if there are equivalent. Motion and bed exit accuracy will be evaluated by comparing with the manual observation.

COMPLETED
Clinical Evaluation of the RHEA Vital Sign Vigilance System in Hospital Patients Patients
Description

This study compares both of the investigational device and reference device to the gold standard Patient Monitor of the accuracy of heart rate and respiratory rate monitoring. The primary variables for the analysis of heart rate (HR) and respiratory rate (RR) are each of the overall mean roots mean square difference (RMSD). Results of the investigational device and reference device compared with the patient monitor is evaluated to see if there are equivalent. Motion and bed exit accuracy will be evaluated by comparing with the manual observation.

COMPLETED
Pilot Clinical Evaluation of the RHEA Vital Sign Vigilance System in Hospital Patients Patients
Description

This study comparing both of the investigational device and reference device to gold standard Patient Monitor of the accuracy of heart rate and respiratory rate monitoring. The primary variables for the analysis of heart rate (HR) and respiratory rate (RR) are each the overall mean root mean square difference (RMSD). Results of the investigational device and reference device compared with the patient monitor are evaluated to see if there are equivalent. Motion and bed exit accuracy will be evaluated by comparing with the manual observation.

COMPLETED
Pilot Clinical Evaluation of the RHEA Vital Sign Vigilance System in Hospital Patients
Description

This study comparing both of the investigational device and reference device to gold standard Patient Monitor of the accuracy of heart rate and respiratory rate monitoring. The primary variables for the analysis of heart rate (HR) and respiratory rate (RR) are each the overall mean root mean square difference (RMSD). Results of the investigational device and reference device compared with the patient monitor are evaluated to see if there are equivalent. Motion and bed exit accuracy will be evaluated by comparing with the manual observation.

COMPLETED
Managing Type 1 and High Risk Type 2 Diabetes in the Hospital Setting: Glucose as a Vital Sign
Description

This program will provide patients with type 1 and high risk type 2 diabetes the safest hospitalization by using wireless continuous glucose monitoring devices (CGM) to track their glucose parameters in real-time similar to other continuously monitored vital signs. The CGM will inform a team of health professionals who will monitor the patients' progress, communicate recommendations, and be available for discussion when recommended targets are not achieved. Health teams will utilize sensor results in addition to existing electronic medical records data to evaluate progress and manage care.

COMPLETED
A Novel Approach to Inpatient Pediatric Physical Activity Measurement - The 6th Vital Sign
Description

The present study aims to establish the feasibility of the clinical use of 3-axis accelerometers to measure physical activity in hospitalized children after elective surgery.

ACTIVE_NOT_RECRUITING
Validating the Use of a Subjectively Reported Sleep Vital Sign
Description

Sleep disorders are commonly under-recognized in the primary care setting and available screening tools are often are limited. The study inestigators hypothesize that the use of a novel subjective sleep vital sign (VS) will improve recognition of patients with sleep disorders and can be utilized to track outcomes to sleep therapy.

COMPLETED
Vital Signs Patch Early Feasibility and Usability Study v1.0
Description

To assess the feasibility and usability of the Vital Signs Patch (VSP) System in the in-patient hospital setting to monitor vital signs using a patch, brain, gateway, and console. The VSP System will be incorporated into the study site's Information Technology infrastructure.

Conditions
COMPLETED
Vital Signs Patch Early Feasibility and Usability Study
Description

To assess the feasibility and usability of the VSP System in the in-patient hospital setting to monitor vital signs using a patch, brain, gateway, and console. The VSP System will be incorporated into the study site's Information Technology infrastructure.

Conditions