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

NCT04450368 | Terminated DMC

• 1 other identifier: 20-30080
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Change and variability fo acoustic resonance

  The change and variability of acoustic resonance features before, during, and after all pulmonary tests, including those where dynamic hyperinflation will be tested: metronome-paced IC, 6-minute walk test and cardio-pulmonary exercise \[every session\]. Acoustic features will be extracted from the measurements with an active acoustic sensor worn on the chest, establishing a baseline before and after all tests. Acoustic resonance changes and their rate of change will be recorded.

  4 hours

• Correlation between acoustic resonance measurements with clinical testing

  The correlation between acoustic resonance measurements and other measurements from pulmonary function tests and wearable devices (respiratory rate, heart rate and oxygen saturation with 80% accuracy rate) before, during (every minute) and after all tests \[every session\]. Acoustic features will be extracted from the measurements with active acoustic sensors worn on the chest. Other measurements will be measured using medical graded devices such as pulse-oximeters and wearables.

  2 hours

Secondary Outcomes (2)

• Correlation between acoustic resonance and symptoms

  1 hour

• Data quality and user experience with medical-grade adhesive

  30 minutes

Study Arms (3)

Cases with Air Trapping

20 COPD patients with lung volumes representing air trapping (RV/TLC and functional residual capacity to TLC \[FRC/TLC\])

Device: Sylvee

Cases without Air Trapping

20 COPD patients without lung volumes representing air trapping (RV/TLC and functional residual capacity to TLC \[FRC/TLC\])

Device: Sylvee

Healthy Controls

Non COPD patients and non-smokers

Device: Sylvee

Interventions

Sylvee DEVICE

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.

Cases with Air Trapping; Cases without Air Trapping; Healthy Controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Outpatients People who have a condition but who are not being seen as patients Students Staff of UCSF or affiliated institutions

You may qualify if:

• Men or women over 40 years old.
• Spirometric COPD.
• A history of smoking at least 20 pack-years.

You may not qualify if:

• Inability to perform lung function testing.
• Inability to complete the study and return for follow-up visits.
• Pregnancy.
• A serious and active heart condition, defined by stable or unstable angina, recent myocardial infarction (within the last 2 years), active or decompensated congestive heart failure or cardiomyopathy.
• End-stage liver disease.
• Patients unable to do mild exercise (patients with orthopedic-neurologic problems; patients who have severe heart failure characterized by an ejection fraction of \<20% or by New York Heart Association Class IV disease; patients who should be at complete rest, confined to a bed or chair; or patients for whom physical activity brings on discomfort and for whom symptoms occur at rest).

Sponsors & Collaborators

• Respira Labs, Inc: lead
• Palo Alto Medical Foundation: collaborator

Study Sites (1)

El Camino Hospital

Mountain View, California, 94040, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ganesh Krishna, MD

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2020
• First Posted: June 29, 2020
• Study Start: March 1, 2022
• Primary Completion: May 30, 2023
• Study Completion: June 1, 2023
• Last Updated: June 18, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)