NCT05713266Completed
Using Data From a Multisensor Rapid Health Assessment Device to Predict Decompensation in Long COVID (AIDI)
AIDI - Research and Development of a Multisensor-Based Technology for Real-time Automated Detection of Post-acute COVID-19 Sequelae
Source: ClinicalTrials.gov · Last updated 16 Oct 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 204 (actual)
- First submitted
- 2 Feb 2023
- Start date
- 31 Oct 2022
- Primary completion date
- 15 Jan 2024
- Lead sponsor
- Edith Nourse Rogers Memorial Veterans Hospital
- NCT number
- NCT05713266
What you commit to
- Study type: Observational
- Participants enrolled: 204
- From 31 Oct 2022 to the primary completion date, 15 Jan 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently receiving hospice care
- Chest, abdominal or eye surgery within the preceding 14 days
Other illness
- Any 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.
Other
- Left-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.
Who the study is looking for
- 18 years of age or older
- Individuals 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 consent
- Has no functional limitation that would impede the use of the MouthLab device, and is able to use the device with the left hand
- Comfortable with using technology
- Can commit to performing the required study tasks
- Can speak/understand English
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| VA Bedford Medical Center Coordinator of this site? Confirm its status | Bedford | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.