Study on Home Obstructive Respiratory Exacerbations (SHORE)

Strados Labs

Status: Invitation-only

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

Treatments: Device: RESP™ Biosensor

Study type: Observational

Funder types: Industry

Identifiers

NCT06544928

SL-RS-SHORE

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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®

Trial design

20 participants in 1 patient group

All Subjects

Description:

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

Treatment:

Device: RESP™ Biosensor