Trials / Enrolling By Invitation
Enrolling By InvitationNCT06544928
Study on Home Obstructive Respiratory Exacerbations
Utility of Remote Lung Auscultation in COPD With RESP™ Biosensor
- Status
- Enrolling By Invitation
- Phase
- —
- Study type
- Observational
- Enrollment
- 20 (estimated)
- Sponsor
- Strados Labs, Inc. · Industry
- Sex
- All
- Age
- 40 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
Strados Labs has developed the Strados™ Respiratory Care Platform, including the RESP™ Biosensor System, which encompasses a clinically validated wearable, non-invasive, Bluetooth-enabled device capable of remotely collecting respiratory data. RESP was designed to extend both the geographical and temporal range of lung sound recordings, which can improve the remote monitoring of high-risk COPD patients. The RESP Biosensor continuously captures lung sounds and chest wall motions that are wirelessly transmitted through a mobile app to a web application to be analyzed for changes in respiratory health. Preliminary data suggest good patient compliance and the potential for RESP to detect early COPD exacerbation. However, uncertainty on the optimal RESP monitoring procedure and insufficient longitudinal RESP data for definitive statistical correlation with COPD exacerbations warrant further study. We plan to conduct an observational study to assess feasibility of home RESP remote patient monitoring and secondarily collect the longitudinal data necessary to establish the correlation between RESP based measures and standard of care measures of COPD symptom severity.
Conditions
- COPD Exacerbation
- COPD (Chronic Obstructive Pulmonary Disease) With Acute Lower Respiratory Infection
- COPD Exacerbation Acute
- COPD
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | RESP™ Biosensor | For this observational study, the RESP™ Biosensor will be placed on the patient for periodic recording of auscultory sound. |
Timeline
- Start date
- 2025-12-05
- Primary completion
- 2026-12-31
- Completion
- 2027-03-31
- First posted
- 2024-08-09
- Last updated
- 2026-01-20
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06544928. Inclusion in this directory is not an endorsement.