Status:
NOT_YET_RECRUITING
Study on Home Obstructive Respiratory Exacerbations
Lead Sponsor:
Strados Labs, Inc.
Conditions:
COPD Exacerbation
COPD (Chronic Obstructive Pulmonary Disease) with Acute Lower Respiratory Infection
Eligibility:
All Genders
40-80 years
Brief Summary
Listening to breath sounds with a stethoscope/auscultation is used by pulmonary physicians in conjunction with pulmonary function, signs and symptoms, oxygen saturation and diagnostic testing to admit...
Eligibility Criteria
Inclusion
- 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
- History of 2 moderate COPD exacerbations and/or 1 severe COPD exacerbation within the past 6 months
- At least 30 days since hospital discharge from COPD exacerbation
- 6-month risk of 20% for moderate exacerbation and 7.5% for severe exacerbation based on ACCEPT score (with possibility of changing to 15% for moderate exacerbation and 5% for severe exacerbation if enrollment is insufficient)
- Tobacco History: Current or Former Smoker
- 1\. Has smoked at least 100 cigarettes in his/her lifetime 6. Patient can follow study procedures, including instructions for self-placement and operation of biosensor
- 1\. Patient has experience/owns a smartphone 7. Patient is accessible by telehealth/telephone for duration of the study 8. Patient is able and willing to return to study site for study visits as necessary
Exclusion
- Patient is unable or unwilling to provide informed consent
- 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®
Key Trial Info
Start Date :
January 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06544928
Start Date
January 1 2025
End Date
March 1 2026
Last Update
December 2 2024
Active Locations (1)
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1
Jefferson Einstein Philadelphia Hospital
Philadelphia, Pennsylvania, United States, 19141