Trials / Withdrawn
WithdrawnNCT05220306
AIDI - Research & Development of a Multisensor-Based Machine Learning Technology for Real-Time Automated Detection of COVID-19 Decompensation
- Status
- Withdrawn
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- AIDAR Health, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2022-01-27
- Primary completion
- 2022-07-31
- Completion
- 2022-07-31
- First posted
- 2022-02-02
- Last updated
- 2023-02-08
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05220306. Inclusion in this directory is not an endorsement.