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Using Data From a Multisensor Rapid Health Assessment Device to Predict Decompensation in Long COVID (AIDI)

NCT05713266 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 204

Last updated 2024-10-16

No results posted yet for this study

Summary

We are conducting a research study at the VA hospital in Bedford, MA to learn more about how a multisensor rapid health assessment device, MouthLab, can help predict or anticipate future health complications in patients with underline conditions after contracting COVID-19. The device was created by a health technology and digital medicine company called Aidar Health, Inc. MouthLab is a non-invasive, hand-held device that works like a breathalyzer. An individual breathes into the device for 60 seconds and the MouthLab gathers more than 10 vital health parameters like temperature, heart rate, SpO2, ECG, and basic lung functions. Participation in the study will last for 6 months, and the purpose is to gather health information from people who have been previously hospitalized with COVID-19. We will use the data to develop an algorithm that predicts future complications of COVID-19, especially among patients with complex conditions (i.e., heart failure, chronic kidney disease, diabetes, hypertension, asthma, chronic obstructive pulmonary disease), and enables early intervention.

Conditions

Interventions

DEVICE

MouthLabTM

Aidar Health's MouthLab device is a non-invasive, hand-held, home monitoring tool that measures multiple clinically meaningful parameters such as temperature, blood pressure, heart rate, heart rate variability, pulse rate, SpO2, single-lead ECG, respiratory rate, breathing pattern, and basic lung functions in 60 seconds.

Sponsors & Collaborators

Principal Investigators

  • Varsha G Vimalananda, MD, MPH · Edith Nourse Rogers Memorial Veterans Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-31
Primary Completion
2024-01-15
Completion
2024-02-29
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05713266 on ClinicalTrials.gov