NCT06544928Enrolling by invitation
Study on Home Obstructive Respiratory Exacerbations
Utility of Remote Lung Auscultation in COPD With RESP™ Biosensor
Source: ClinicalTrials.gov · Last updated 20 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Observational
- Enrollment
- 20 (estimated)
- First submitted
- 5 Aug 2024
- Start date
- 5 Dec 2025
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Strados Labs, Inc.
- Diseases
- COPD
- NCT number
- NCT06544928
What you commit to
- Study type: Observational
- Planned participants: 20
- From 5 Dec 2025 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Any condition that, in the opinion of the investigator, would limit the patient's activity in the study and/or adequate lung sound capture using the RESP™ wearable device
- Patient with end-stage medical condition with expected survival no more than 6 months
- History of adverse reaction or allergy to adhesives such as TegaDerm®
Other
- Patient is unable or unwilling to provide informed consent
Who the study is looking for
- 1\. Males and females between the ages of 40 and 80 with documented physician-diagnosed COPD and FEV1/FVC\<0.70 or LLN based on post-bronchodilator spirometry
- Hospitalized for COPD exacerbation with plan for discharge within 48 hours OR
- Visiting pulmonologist post COPD-exacerbation within 14 days of discharge from hospital 3. Tobacco History: Current or Former Smoker
- Has smoked at least 100 cigarettes in his/her lifetime 4. Patient can follow study procedures, including instructions for self-placement and operation of biosensor
- Patient has experience/owns a smartphone 5. Patient is accessible by telehealth/telephone for duration of the study 6. Patient is able and willing to return to study site for study visits as necessary
Age in the registry: 40 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Jefferson Einstein Philadelphia Hospital Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.