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

NCT05713266 | Completed FDA Device

• 1 other identifier: 1720661-2
• Study Type: observational
• Target: 204
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19; Long COVID

Keywords

COVID-19; decompensation; long COVID-19; device; chronic kidney disease; diabetes; hypertension; asthma; chronic obstructive pulmonary diseaes; heart failure

Outcome Measures

Primary Outcomes (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)

  6 months

Secondary Outcomes (6)

• All new diagnoses, treatment, utilization, medication

  6 months

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

  6 months

• Survey data

  baseline, monthly and end of studu

• All cause healthcare utilization (within and outside VA)

  6 months

• Highly likely COVID-19 related healthcare utilization

  6 months

Study Arms (1)

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.

Device: MouthLabTM

Interventions

MouthLabTM DEVICE

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.

Severe COVID-19 survivors

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Edith Nourse Rogers Memorial Veterans Hospital: lead
• AIDAR Health, Inc.: collaborator
• Biomedical Advanced Research and Development Authority: collaborator

Study Sites (1)

VA Bedford Medical Center

Bedford, Massachusetts, 01730, United States

Location

Related Publications (1)

• 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.

  PMID: 40334212 DERIVED

MeSH Terms

Conditions

COVID-19; Post-Acute COVID-19 Syndrome; Renal Insufficiency, Chronic; Diabetes Mellitus; Hypertension; Asthma; Heart Failure

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Heart Diseases

Study Officials

• Varsha G Vimalananda, MD, MPH

  Edith Nourse Rogers Memorial Veterans Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician-Scientist

Study Record Dates

• First Submitted: February 2, 2023
• First Posted: February 6, 2023
• Study Start: October 31, 2022
• Primary Completion: January 15, 2024
• Study Completion: February 29, 2024
• Last Updated: October 16, 2024

Record last verified: 2024-10

Locations

US (1)