Study on Home Obstructive Respiratory Exacerbations

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.

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Key information

Conditions

COPD Exacerbation COPD COPD (Chronic Obstructive Pulmonary Disease) With Acute Lower Respiratory Infection COPD Exacerbation Acute Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Jefferson Einstein Philadelphia Hospital

Philadelphia, Pennsylvania, 19141, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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®

Treatment and study plan

RESP™ Biosensor

Device

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

Primary outcomes

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

Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Strados Labs, Inc.

Industry

Registry information

Official study title

Utility of Remote Lung Auscultation in COPD With RESP™ Biosensor

Acronym: SHORE

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2027
First posted: Aug 9, 2024
Registry last updated: Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed