Study on Home Obstructive Respiratory Exacerbations

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Strados Labs, Inc.
Study ID
NCT06544928
Status
Enrolling By Invitation

Conditions

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

Eligibility Criteria

Sex
ALL
Age
40 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Dec 5, 2025
Status verified
Jan 2026
Primary completion
Dec 31, 2026
Completion
Mar 31, 2027

Study Design

Enrollment
20 participants (estimated)

Arms

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

Primary Outcome Measure

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

Locations (1)

FacilityCityStateZIPSite coordinators
Jefferson Einstein Philadelphia HospitalPhiladelphiaPennsylvania19141-

Find similar trials in Philadelphia, PA

By condition
COPD
By specialty
PulmonologyLung disease
By research site
Jefferson Einstein Philadelphia Hospital· Philadelphia, PA

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