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All Subjects for Chronic Obstructive Pulmonary Disease (SHORE Trial)

N/A
Waitlist Available
Research Sponsored by Strados Labs, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up recordings started prior to bedtime and continue for at least 6 hours, every other sleep for 6 months.
Awards & highlights

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recording both geographically and temporally to improve the standard of care when access to continuous monitoring has been replaced by periodic or no monitoring.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.

Eligible Conditions
  • Chronic Obstructive Pulmonary Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~recordings started prior to bedtime and continue for at least 6 hours, every other sleep for 6 months.
This trial's timeline: 3 weeks for screening, Varies for treatment, and recordings started prior to bedtime and continue for at least 6 hours, every other sleep for 6 months. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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
Secondary study objectives
Univariate and multivariate assessment of predictors of up to 6-month total respiratory exacerbation rate (moderate + severe)

Trial Design

1Treatment groups
Experimental Treatment
Group I: All SubjectsExperimental Treatment1 Intervention
Device: RESP Biosensor The RESP Biosensor will be placed on the patient for recording of auscultory sound. Other Names: RESP

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Who is running the clinical trial?

Strados Labs, Inc.Lead Sponsor
4 Previous Clinical Trials
66 Total Patients Enrolled
~13 spots leftby Sep 2025