Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 4:20 PM
Ignite Modification Date:
2025-12-24 @ 4:20 PM
NCT ID:
NCT05713266
Brief 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.
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:
NCT05713266
Study Brief:
Protocol Section:
NCT05713266