Study on Home Obstructive Respiratory Exacerbations (SHORE)

Utility of Remote Lung Auscultation in COPD With RESP™ Biosensor

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: COPD; COPD Exacerbation; COPD Exacerbation Acute; COPD (Chronic Obstructive Pulmonary Disease) With Acute Lower Respiratory Infection
• Intervention / Treatment: Device: RESP™ Biosensor

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19141
      • Jefferson Einstein Philadelphia Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Subjects who are hospitalized for COPD exacerbation with plan for discharge within 48 hoursare, OR are visiting their pulmonologist in the outpatient setting or via telehealth within 14 days of a COPD exacerbation with inpatient stay.

Description

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

• 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

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®

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
All Subjects; Device: RESP Biosensor The RESP Biosensor will be placed on all qualitfying subjects for recording of auscultory sound.	Device: RESP™ Biosensor; For this observational study, the RESP™ Biosensor will be placed on the patient for periodic recording of auscultory sound.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The study will assess observational outcome measures. No formal efficacy or safety endpoints are defined.	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Univariate and multivariate assessment of predictors of up to 6-month total respiratory exacerbation rate (moderate + severe)	Recordings started prior to bedtime and continue for at least 6 hours, every other sleep for 6 months.

Collaborators and Investigators

• Sponsor: Strados Labs, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: August 5, 2024
• First Submitted That Met QC Criteria: August 5, 2024
• First Posted (Actual): August 9, 2024

Study Record Updates

• Last Update Posted (Actual): January 20, 2026
• Last Update Submitted That Met QC Criteria: January 15, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: SHORE; SL-RS-SHORE; RESP™ Biosensor; RESP™; Strados Labs
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pathological Conditions, Signs and Symptoms; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: SL-RS-SHORE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No