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.
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
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 group | Role | What they receive |
|---|---|---|
| Severe COVID-19 survivors | Adult 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.
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)
All new diagnoses, treatment, utilization, medication
All new diagnoses, treatment, utilization, medication
Measured: 6 months
Highly likely COVID-19 related diagnoses, treatment, utilization, medication
Highly likely COVID-19 related diagnoses, treatment, utilization, medication
Measured: 6 months
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
All cause healthcare utilization (within and outside VA)
All cause healthcare utilization (within and outside VA)
Measured: 6 months
Highly likely COVID-19 related healthcare utilization
Highly likely COVID-19 related healthcare utilization
Measured: 6 months
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.
- First posted6 Feb 2023
- Study start31 Oct 2022
- Primary completion15 Jan 2024
- Study completion29 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Edith Nourse Rogers Memorial Veterans Hospital
- Sponsor type
- US federal agency
- Collaborators
- AIDAR Health, Inc., Biomedical Advanced Research and Development Authority
- Responsible party
- Principal investigator, Varsha Vimalananda, MD, MPH, Edith Nourse Rogers Memorial Veterans Hospital
- Investigators
- Varsha G Vimalananda, MD, MPH, Principal investigator, Edith Nourse Rogers Memorial Veterans Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AIDI - Research and Development of a Multisensor-Based Technology for Real-time Automated Detection of Post-acute COVID-19 Sequelae
- ClinicalTrials.gov ID
- NCT05713266
- Acronym / sponsor ID
- AIDI / 1720661-2
- Conditions
- COVID-19, Long COVID
- Keywords
- COVID-19, decompensation, long COVID-19, device, chronic kidney disease, diabetes, hypertension, asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Edith Nourse Rogers Memorial Veterans HospitalUS federal agency
- Collaborators
- AIDAR Health, Inc., Biomedical Advanced Research and Development Authority
- Study start
- 31 Oct 2022 (actual)
- Primary completion
- 15 Jan 2024 (actual)
- Study completion
- 29 Feb 2024 (actual)
- First posted
- 6 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Severe COVID-19 survivors | – | Device: MouthLabTMAdult 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have tested positive for SARS-CoV-2 and required COVID-19 related hospitalization during the acute phase.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MouthLabTMAidar 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. | Device | Severe COVID-19 survivors |
Primary outcome
All cause higher level of care utilization
Time frame: 6 months
All cause higher level of care healthcare utilization (hospitalization, ER, or urgent care visits within VA system)
6 secondary outcomes
All new diagnoses, treatment, utilization, medication
Time frame: 6 months
Highly likely COVID-19 related diagnoses, treatment, utilization, medication
Time frame: 6 months
Survey data
Time frame: baseline, monthly and end of studu
All cause healthcare utilization (within and outside VA)
Time frame: 6 months
Highly likely COVID-19 related healthcare utilization
Time frame: 6 months
Highly likely+somewhat likely COVID-19 related healthcare utilization
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
- Derived from this study: PubMed 40334212Pagliaro 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Varsha G Vimalananda, MD, MPH principal investigator
Edith Nourse Rogers Memorial Veterans Hospital
1 site in 1 country: see every site and its status.
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.