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NCT05713266
Using Data From a Multisensor Rapid Health Assessment Device to Predict Decompensation in Long COVID (AIDI)
Conditions: COVID-19, Long COVID
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: 1
Enrollment: 400
Sponsor: Edith Nourse Rogers Memorial Veterans Hospital
Location: United States
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.
Eligibility Criteria
Inclusion Criteria:18 years of age or olderIndividuals who have had a COVID-19 related hospitalization (3-6 months prior to enrollment)Has at least one specified comorbidity (Diabetes, Heart Failure, Hypertension, Chronic Kidney Disease, Asthma, or COPD)Willing and able to provide informed consentHas no functional limitation that would impede the use of the MouthLab device, and is able to use the device with the left handComfortable with using technologyCan commit to performing the required study tasksCan speak/understand EnglishExclusion Criteria:Currently receiving hospice careLeft-sided hemiplegia or any other motor deficits that may restrict the use of the device.Individuals with cognitive deficits that impede their ability to comprehend and give informed consent.Chest, abdominal or eye surgery within the preceding 14 daysAny condition that in the judgment of the investigators would interfere with the subject's ability to provide informed consent, comply with study instructions, place the subject at increased risk, or which might confound interpretation of study results.
Source: ClinicalTrials.gov (NCT05713266). StuddyBuddy aggregates publicly available trial information.