MedTrace Logo

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

NCT04450368 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 8

Last updated 2023-06-18

No results posted yet for this study

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.

Conditions

  • COPD
  • COPD Exacerbation

Interventions

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.

Sponsors & Collaborators

  • Palo Alto Medical Foundation

    collaborator OTHER

  • Respira Labs, Inc

    lead INDUSTRY

Principal Investigators

  • Ganesh Krishna, MD · Principal Investigator

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-01
Primary Completion
2023-05-30
Completion
2023-06-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04450368 on ClinicalTrials.gov