NCT04450368

Clinical Feasibility of a Non-invasive Wearable Acoustic Device for Measuring Air Trapping in COPD

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 8 (actual)
• Sponsor: Respira Labs, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

This is a pilot observational study during which the investigators will conduct a longitudinal assessment of air trapping (with up to 2 visits) in 40 patients with COPD and variable degrees of air trapping and 20 healthy controls using ARIA. The investigators will characterize the clinical phenotype of the subjects by administering health and symptom-based questionnaires and obtaining lung function testing at rest and during exertion, and will then correlate and validate the ARIA-based indices with those of the more traditional physiologic measures of static and dynamic air trapping.

Detailed description

Chronic Obstructive Pulmonary Disease (COPD) is the fourth leading cause of hospitalization in the United States. Exacerbations, a worsening or "flare up" of symptoms cause most COPD hospitalizations. Early detection of lung function deterioration would facilitate early intervention and help prevent hospitalizations, since most exacerbations can be treated with changes of inhalers and/or oral medications. Air trapping, defined as an abnormal increase in the volume of air remaining in the lungs after exhalation, is a common finding in all forms of COPD. Air trapping has been shown to increase during exacerbations and decrease when exacerbations resolve. Moreover, increasing recent evidence indicates that air trapping is an earlier harbinger of deteriorating lung function than spirometric changes. Recent research shows that lung air trapping can be measured by low-frequency ultrasound (1-40 kHz). Thus, acoustic monitoring of air trapping could provide clinicians with a non-invasive tool to when medical intervention is needed to avoid unnecessary ER visits and hospitalizations. The investigators have developed a low-cost, non-invasive, acoustic-based wearable device, Sylvee that is capable of continuous monitoring of lung resonance. The device has machine-learning algorithms that can detect minor changes in lung resonance, which our preliminary results suggest corresponds to changes in air trapping. The overall objective of this pilot project is to validate Sylvee's algorithms in a cohort of 60 patients with COPD and variable degree of air trapping. Ultimately, Sylvee will allow physicians to remotely monitor their patients' lung function and adjust their medications to reduce healthcare costs and improve patients' quality of life.

Conditions

• COPD
• COPD Exacerbation

Interventions

Type	Name	Description
DEVICE	Sylvee	The investigators have developed a small sensor that has the same characteristics as a combined hearing aid used for Tinnitus. It has a noise generator intended to transmit white noise (2 - 20 KHz) and a microphone similar to those used in hearing aids to provide sound amplification. Our sensor is substantially equivalent to legally FDA approved marketed devices that can be used for several hours per day. Although it will introduce new indications for use (lung resonance capture), it has the same technological characteristics and will not introduce new hazards or safety risks. Several sound-based devices are already in use for clearing mucus from the lungs by generating and delivering low frequency sound that vibrates the airways and lung secretions, causing them to thin and become expelled. The devices are placed on the patient's chest for up to 3-4 hours in COPD, cystic fibrosis (CF) and other lung diseases.

Timeline

• Start date: 2022-03-01
• Primary completion: 2023-05-30
• Completion: 2023-06-01
• First posted: 2020-06-29
• Last updated: 2023-06-18

Locations

1 site across 1 country: United States