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COVID-19AIDINCT05713266

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

An observational study of COVID-19 and Long COVID, run by Edith Nourse Rogers Memorial Veterans Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
COVID-19, Long COVID
What is being tested?
MouthLabTM
Type of treatment
Medical device
How many people
204 participants
Where
1 siteUnited States
Study dates
31 Oct 2022to 29 Feb 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Patients who have tested positive for SARS-CoV-2 and required COVID-19 related hospitalization during the acute phase.

Who may be able to join

  • 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

Who cannot join

  • Currently receiving hospice care
  • 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.
  • Chest, abdominal or eye surgery within the preceding 14 days
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • VA Bedford Medical Center

    Bedford, Massachusetts, 01730

Other trials in United States

About this study

Official title: AIDI - Research and Development of a Multisensor-Based Technology for Real-time Automated Detection of Post-acute COVID-19 Sequelae

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.

Read the detailed description

Severe complications like post-acute thrombosis, respiratory failure, and cardiac and vascular damage may increase the likelihood of future morbidity and mortality in recovered COVID-19 patients. Although the current rate of new COVID-19 infection has dropped, the risk of morbidity, mortality, and organ dysfunction among the survivors of COVID-19 infection is significant. An association between COVID-19 and an increased odds of acute kidney injury, renal replacement treatment, use of insulin, pulmonary embolism, stroke, myocarditis, arrhythmia, and increased troponin was found in US veterans admitted to hospital with COVID-19 versus a control group of patients with seasonal influenza. This comparative approach to examining post-acute sequelae in individuals who are hospitalized with COVID-19 versus individuals with seasonal influenza (using a high-dimensional approach and thorough examination of prespecified outcomes) suggests that there is a substantially higher burden of a broad array of post-acute sequelae in the individuals who are hospitalized with COVID-19, which provides features that differentiate post-acute COVID-19 (both in the magnitude of risk and the breadth of organ involvement) from a post-influenza viral syndrome.

Given the prevalence rates, it is evident that individuals in the post-acute phase even 12-months after their initial diagnosis continue to have abnormal physiological characteristics and increased utilization of healthcare resources as a consequence of altered health. This forces the conclusion that COVID-19 needs to be treated as a 'chronic condition' exhibiting an increased risk of morbidity, use of healthcare resources as well as a substantial burden of health loss that spans across pulmonary and extrapulmonary organ systems. From evidence and reasoning, it would be appropriate to infer that the next wave related to COVID-19 may not necessarily be a new strain but rather the surge of hospitalizations due to post-acute complications. Therefore, developing holistic and multidisciplinary long-term care strategies for patients with COVID-19 is emerging as an unmet need. To address these knowledge gaps, this study aims to recruit 'severe COVID-19' cases (i.e. those who required hospitalization during the acute COVID-19 phase), who have increased rates of multiorgan failure compared with the expected risk in the general population, to characterize the changes in cardiorespiratory parameters leading up to a decompensation event. Early prediction, real-time risk triaging shall be invaluable for better clinical decision making, preventing complications, controlling disease progression and improving outcomes.

Conditions
COVID-19, Long COVID
Being tested
MouthLabTM
Keywords
COVID-19, decompensation, long COVID-19, device, chronic kidney disease, diabetes, hypertension, asthma, chronic obstructive pulmonary diseaes, heart failure
Medical subject headings
COVID-19, Post-Acute COVID-19 Syndrome, Renal Insufficiency, Chronic, Diabetes Mellitus, Hypertension, Asthma, Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MouthLabTMDevice

    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.

Study groups in NCT05713266
Study groupRoleWhat they receive
Severe COVID-19 survivorsAdult COVID-19 survivors who had 'severe COVID-19' during the acute phase and have at least one of the following pre-existing conditions: Hypertension, Asthma, COPD, Heart Failure, Chronic kidney disease and/or Diabetes. 'Severe COVID-19' is defined as requiring hospital or intensive level care for treatment of the infection and its complications.
Receives: Device: MouthLabTM

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All cause higher level of care utilization

    All cause higher level of care healthcare utilization (hospitalization, ER, or urgent care visits within VA system)

    Measured: 6 months

Secondary outcomes (6)
  1. All new diagnoses, treatment, utilization, medication

    All new diagnoses, treatment, utilization, medication

    Measured: 6 months

  2. Highly likely COVID-19 related diagnoses, treatment, utilization, medication

    Highly likely COVID-19 related diagnoses, treatment, utilization, medication

    Measured: 6 months

  3. Survey data

    • Survey data
    • Self-reported presence of the following outcomes: (once a month)
    • MRC Dyspnea Scale (Score 1-5)
    • Post COVID-19 functional status scale (0-4 grade scale)
    • VR-12 Quality of Life Assessment (before and after the study)
    • MouthLab Usability Survey (Only after the study)
    • User Feedback on Remote Physiological Monitoring (RPM) technology

    Measured: baseline, monthly and end of studu

  4. All cause healthcare utilization (within and outside VA)

    All cause healthcare utilization (within and outside VA)

    Measured: 6 months

  5. Highly likely COVID-19 related healthcare utilization

    Highly likely COVID-19 related healthcare utilization

    Measured: 6 months

  6. Highly likely+somewhat likely COVID-19 related healthcare utilization

    Highly likely+somewhat likely COVID-19 related healthcare utilization

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Feb 2023
  2. Study start31 Oct 2022
  3. Primary completion15 Jan 2024
  4. Study completion29 Feb 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
204 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05713266
Sponsor's protocol ID
1720661-2
Acronym
AIDI
Status last verified
Oct 2024
First submitted
2 Feb 2023
Last updated
16 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes

Publications

  • Pagliaro JA, Wash LK, Ly K, Mathew J, Leibowitz A, Cabrera R, Wormwood JB, Vimalananda VG. Enrollment and Retention Outcomes from the Veterans Health Administration for a Remote Digital Health Study: Multisite Observational Study. JMIR Form Res. 2025 Aug 15;9:e68676. doi: 10.2196/68676.

    PubMed 40334212

Questions about this trial

What is this clinical trial studying?

An observational study of COVID-19 and Long COVID, run by Edith Nourse Rogers Memorial Veterans Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All cause higher level of care utilization (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05713266, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2024.

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AIDI Clinical Trial NCT05713266 | AzTrials