Clinical trial NCT06544928: Study on Home Obstructive Respiratory Exacerbations
Official title: Utility of Remote Lung Auscultation in COPD with RESP™ Biosensor
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: COPD Exacerbation
COPD (Chronic Obstructive Pulmonary Disease) with Acute Lower Respiratory Infection
COPD Exacerbation Acute
COPD
Lead sponsor: Strados Labs, Inc.
Sponsor class: INDUSTRY
First posted: 2024-08-09
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who are visiting their pulmonologist in the outpatient setting or via telehealth visit with study team within 30 days of a COPD exacerbation with inpatient stay.

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, follow, and discharge patients from the hospital. Of these, only auscultation routinely ceases upon discharge from the hospital. Healthcare utilization statistics have shown that for more than a decade, readmission after discharge for an exacerbation of COPD remains a major problem. The Strados RESP Biosensor has been designed to extend the range of lung sound recording both geographically and temporally to improve the standard of care when access to continuous monitoring has been replaced by periodic or no monitoring. The primary purpose of this study is to assess the associations between RESP Biosensor-acquired lung findings and subjective measures of respiratory symptoms as measured by validated measurement tools, and objective measure of respiratory physiology as determined by home pulse oximetry.


Eligibility criteria: Inclusion Criteria:

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
2. History of 2 moderate COPD exacerbations and/or 1 severe COPD exacerbation within the past 6 months
3. At least 30 days since hospital discharge from COPD exacerbation
4. 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)
5. 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 Criteria:

1. Patient is unable or unwilling to provide informed consent
2. 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
3. Patient with end-stage medical condition with expected survival no more than 6 months
4. History of adverse reaction or allergy to adhesives such as TegaDerm®

Primary outcomes:
measure: Statistically significant associations between RESP Biosensor-acquired lung findings and 1) subjective measure of respiratory symptoms measured by validated measurements tools and 2) home spirometry
timeFrame: Recordings started prior to bedtime and continue for at least 6 hours, every other sleep for 6 months.
Secondary outcomes:
measure: Univariate and multivariate assessment of predictors of up to 6-month total respiratory exacerbation rate (moderate + severe)
timeFrame: Recordings started prior to bedtime and continue for at least 6 hours, every other sleep for 6 months.
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Jefferson Einstein Philadelphia Hospital
state: Pennsylvania
Study officials:
References: