Study on Home Obstructive Respiratory Exacerbations

NCT06544928 · tracked via the Priya Life Science USA tracker

Sponsor

Strados Labs, Inc.

Phase

Observational

Started

2025-12-05

Last updated

2026-01-20

Condition(s) studied

COPD ExacerbationCOPD (Chronic Obstructive Pulmonary Disease) With Acute Lower Respiratory InfectionCOPD Exacerbation AcuteCOPD

Investigational drug(s) / intervention(s)

RESP™ Biosensor

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

Study 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.

Eligibility

Sex

ALL

Min age

40 Years

Max age

80 Years

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®

Primary outcome measure(s)

The study will assess observational outcome measures. No formal efficacy or safety endpoints are defined. — 12 months

Trial sites (1)

Facility	City	Region	Status
Jefferson Einstein Philadelphia Hospital	Philadelphia	Pennsylvania

Other trials for the same condition

A Multi Center Study Testing a New Implant for Adults With Severe Emphysema Recruiting

A Study to Evaluate Solrikitug in Participants With COPD (ZION) Active, not recruiting

Evaluation of the Safety and Efficacy of TLD in Patients with COPD Active, not recruiting

Closed Loop Oxygen Control in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Nasal High Flow in the Hospital Recruiting

Early Detection of COPD Exacerbations Using Home Monitoring Device Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06544928 on ClinicalTrials.gov ↗ ← All trials in the USA