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AIDI - Research & Development of a Multisensor-Based Machine Learning Technology for Real-Time Automated Detection of COVID-19 Decompensation

NCT05220306 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2023-02-08

No results posted yet for this study

Summary

The AIDI study has to phases. It's purpose is to capture vital signs using a non-invasive, hand-held, home monitoring device (MouthLab Device) from individuals with COVID-19 or who test positive for SARS-CoV-2 (Phase I) and use an algorithm-based approach to identify individuals at risk of clinical decompensation (Phase II). Up to 500 unvaccinated and partially vaccinated subjects will be included (up to 100 in Phase I and up to 400 in Phase II).

Conditions

Interventions

DEVICE

Monitoring of vital signs

The MouthLab is a hand-held device. The user holds the unit in their left hand with the Mouthpiece between the teeth and lips and breathes normally into the device for 30 seconds.

Sponsors & Collaborators

  • Avania

    collaborator INDUSTRY

  • AIDAR Health, Inc.

    lead INDUSTRY

Principal Investigators

  • Sujith Shetty, MD · Avania

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-27
Primary Completion
2022-07-31
Completion
2022-07-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05220306 on ClinicalTrials.gov