Study on Home Obstructive Respiratory Exacerbations

Not yet recruiting

• Conditions: COPD Exacerbation; COPD (Chronic Obstructive Pulmonary Disease) with Acute Lower Respiratory Infection; COPD Exacerbation Acute; COPD
• Interventions: Device: RESP Biosensor

• Registration Number: NCT06544928
• Lead Sponsor: Strados Labs, Inc.

Brief Summary

Listening to breath sounds with a stethoscope/auscultation is used by pulmonary physicians in conjunction with pulmonary function, signs and symptoms, oxygen saturation and diagnostic testing to admit, follow, and discharge patients from the hospital. Of these, only auscultation routinely ceases upon discharge from the hospital. Healthcare utilization statistics have shown that for more than a decade, readmission after discharge for an exacerbation of COPD remains a major problem. The Strados RESP Biosensor has been designed to extend the range of lung sound recording both geographically and temporally to improve the standard of care when access to continuous monitoring has been replaced by periodic or no monitoring. The primary purpose of this study is to assess the associations between RESP Biosensor-acquired lung findings and subjective measures of respiratory symptoms as measured by validated measurement tools, and objective measure of respiratory physiology as determined by home pulse oximetry.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-05
• Study First Submitted QC: 2024-08-05
• Study First Posted: 2024-08-09
• Last Update Submitted: 2024-11-26
• Last Update Posted: 2024-12-02
• Study Start: 2025-01-01
• Primary Completion: 2025-12-01
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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

2. History of 2 moderate COPD exacerbations and/or 1 severe COPD exacerbation within the past 6 months

3. At least 30 days since hospital discharge from COPD exacerbation

4. 6-month risk of 20% for moderate exacerbation and 7.5% for severe exacerbation based on ACCEPT score (with possibility of changing to 15% for moderate exacerbation and 5% for severe exacerbation if enrollment is insufficient)

5. Tobacco History: Current or Former Smoker

6. Has smoked at least 100 cigarettes in his/her lifetime 6. Patient can follow study procedures, including instructions for self-placement and operation of biosensor

7. Patient has experience/owns a smartphone 7. Patient is accessible by telehealth/telephone for duration of the study 8. 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®

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All Subjects	RESP Biosensor	Device: RESP Biosensor The RESP Biosensor will be placed on the patient for recording of auscultory sound. Other Names: RESP

Primary Outcome Measures

Name	Time	Method
Statistically significant associations between RESP Biosensor-acquired lung findings and 1) subjective measure of respiratory symptoms measured by validated measurements tools and 2) home spirometry	Recordings started prior to bedtime and continue for at least 6 hours, every other sleep for 6 months.

Secondary Outcome Measures

Name	Time	Method
Univariate and multivariate assessment of predictors of up to 6-month total respiratory exacerbation rate (moderate + severe)	Recordings started prior to bedtime and continue for at least 6 hours, every other sleep for 6 months.

Trial Locations

Locations (1)

Jefferson Einstein Philadelphia Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States