COPDNCT04450368
Clinical Feasibility of a Non-invasive Wearable Acoustic Device for Measuring Air Trapping in COPD
An observational study of COPD and COPD Exacerbation, run by Respira Labs, Inc at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD, COPD Exacerbation
- What is being tested?
- Sylvee
- Type of treatment
- Medical device
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2022to 1 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Outpatients People who have a condition but who are not being seen as patients Students Staff of UCSF or affiliated institutions
Who may be able to join
- Men or women over 40 years old.
- Spirometric COPD.
- A history of smoking at least 20 pack-years.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Sylvee
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SylveeDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Cases with Air Trapping | 20 COPD patients with lung volumes representing air trapping (RV/TLC and functional residual capacity to TLC [FRC/TLC]) Receives: 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]) Receives: Device: Sylvee | |
| Healthy Controls | Non COPD patients and non-smokers Receives: Device: Sylvee |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 2 hours
Secondary outcomes (2)
Correlation between acoustic resonance and symptoms
The correlation between acoustic resonance measurements and patient symptoms and vitals before, during and after all pulmonary function 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. Patient symptoms and vitals will be collected before and after all tests.
Measured: 1 hour
Data quality and user experience with medical-grade adhesive
The correlation between medical-grade adhesive options, session length, data quality and patient experience with sensor attachment and detachment procedures. For example: Medical-grade adhesive options will be presented to users at different sessions. Ease of setup, attachment, detachment and data quality will be recorded on a questionnaire for further correlation. A questionnaire with scales from easy-to-hard will be prepared to allow for quantification of different options. The correlation between companion app screens and flows: ease of performing tasks, reading measurements and free-form feedback. Pre-selected alternative application screens, flows and options will be shown to the user in the mobile app and their feedback recorded (free form notes) for User Experience iteration.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2020
- Study start1 Mar 2022
- Primary completion30 May 2023
- Study completion1 Jun 2023
Why it stopped: Site failed to hit recruitment targets
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Respira Labs, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Palo Alto Medical Foundation
- Responsible party
- Sponsor
- Investigators
- Ganesh Krishna, MD, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04450368
- Sponsor's protocol ID
- 20-30080
- Status last verified
- Jun 2023
- First submitted
- 24 Jun 2020
- Last updated
- 18 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Feasibility of a Non-invasive Wearable Acoustic Device for Measuring Air Trapping in COPD
- ClinicalTrials.gov ID
- NCT04450368
- Acronym / sponsor ID
- 20-30080
- Conditions
- COPD, COPD Exacerbation
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Site failed to hit recruitment targets
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Respira Labs, IncIndustry (pharma, biotech, devices)
- Collaborators
- Palo Alto Medical Foundation
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 29 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cases with Air Trapping | – | Device: Sylvee20 COPD patients with lung volumes representing air trapping (RV/TLC and functional residual capacity to TLC [FRC/TLC]) |
| Cases without Air Trapping | – | Device: Sylvee20 COPD patients without lung volumes representing air trapping (RV/TLC and functional residual capacity to TLC [FRC/TLC]) |
| Healthy Controls | – | Device: SylveeNon COPD patients and non-smokers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Outpatients People who have a condition but who are not being seen as patients Students Staff of UCSF or affiliated institutions
Key inclusion criteria (3 listed)
- Men or women over 40 years old.
- Spirometric COPD.
- A history of smoking at least 20 pack-years.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SylveeThe 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. | Device | Cases with Air Trapping, Cases without Air Trapping, Healthy Controls |
Primary outcome
Change and variability fo acoustic resonance
Time frame: 4 hours
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.
Correlation between acoustic resonance measurements with clinical testing
Time frame: 2 hours
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 secondary outcomes
Correlation between acoustic resonance and symptoms
Time frame: 1 hour
Data quality and user experience with medical-grade adhesive
Time frame: 30 minutes
Results and safety
The study was stopped early (reason given: Site failed to hit recruitment targets). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ganesh Krishna, MD principal investigator
Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD and COPD Exacerbation, run by Respira Labs, Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Site failed to hit recruitment targets). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change and variability fo acoustic resonance (time frame: 4 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2023.