SHORENCT06544928

Study on Home Obstructive Respiratory Exacerbations

StatusEnrolling by Invitation

PhaseNot specified

SponsorStrados Labs, Inc.

Primary completionMar 31, 2027 (estimated)

At risk: Primary completion moved 3 months later.

See at-risk trials from Strados Labs, Inc.

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Record History

All 4 versions: 4 with changes below. See every version on ClinicalTrials.gov ↗

Notable Nov 12, 2026 Eligibility criteria expanded, about 8 words
- Primary completion pushed from Dec 31, 2026 to Mar 31, 2027
- Study completion pushed from Mar 31, 2027 to May 31, 2027
- Study site revised
Notable Jan 15, 2026 Trial status: Not Yet Recruiting to Enrolling by Invitationv3 Show 8 more changesShow less
- Primary completion date: Dec 1, 2025 to Dec 31, 2026
- Start date changed from estimate of Jan 1, 2025 to Dec 5, 2025
- Eligibility criteria shortened, about 37 words
- Primary endpoint revised
- Study completion date: Mar 1, 2026 to Mar 31, 2027
- Interventions: RESP Biosensor (Device) to RESP™ Biosensor (Device)
- Secondary endpoints shortened, about 17 words
- Site contact updated
Notable Nov 26, 2024 Start date: Sep 30, 2024 to Jan 1, 2025
- Primary completion date: Sep 30, 2025 to Dec 1, 2025
- Study completion date: Oct 1, 2025 to Mar 1, 2026
- Site contact updated
v2
Aug 5, 2024 Study First Submitted

Notable: the plan changed

Endpoints

Primary

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

Timeframe: 12 months

Arms and interventions

All Subjects

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

Devices: RESP™ Biosensor

Sites

1 site in 1 country

Rutgers Robert Wood Johnson Medical School (RWJMS)New Brunswick, New Jersey, United States

About this trial

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.

Trial details

Enrollment: 20 participants (estimated)
Started: Dec 5, 2025
Study completion: May 31, 2027 (estimated)
Eligibility: 40 to 80, all sexes, no healthy volunteers
Design: Observational
Oversight: No data monitoring committee, FDA-regulated device
Conditions: Pulmonary Disease, Chronic Obstructive, COPD Exacerbation, COPD (Chronic Obstructive Pulmonary Disease) With Acute Lower Respiratory Infection, COPD Exacerbation Acute, COPD
Official title: Utility of Remote Lung Auscultation in COPD With RESP™ Biosensor
First posted: Aug 9, 2024
Registry updated: Nov 13, 2026
Last verified: Nov 2026

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