Study on Home Obstructive Respiratory Exacerbations

NCT06544928 | Enrolling By Invitation FDA Device

• 1 other identifier: SL-RS-SHORE
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COPD; COPD Exacerbation; COPD (Chronic Obstructive Pulmonary Disease) With Acute Lower Respiratory Infection; COPD Exacerbation Acute

Keywords

SHORE; SL-RS-SHORE; RESP™ Biosensor; RESP™; Strados Labs

Outcome Measures

Primary Outcomes (1)

• The study will assess observational outcome measures. No formal efficacy or safety endpoints are defined.

  12 months

Study Arms (1)

All Subjects

Device: RESP Biosensor The RESP Biosensor will be placed on all qualitfying subjects for recording of auscultory sound.

Device: RESP™ Biosensor

Interventions

RESP™ Biosensor DEVICE

For this observational study, the RESP™ Biosensor will be placed on the patient for periodic recording of auscultory sound.

All Subjects

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \. 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

You may not qualify if:

• 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®

Sponsors & Collaborators

• Strados Labs, Inc.: lead

Study Sites (1)

Jefferson Einstein Philadelphia Hospital

Philadelphia, Pennsylvania, 19141, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2024
• First Posted: August 9, 2024
• Study Start: December 5, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: January 20, 2026

Record last verified: 2026-01

Locations

US (1)