Chronic Obstructive Pulmonary Disease (COPD)NCT05661435
Utility of Remote Lung Auscultation in Transitions of Care After Pulmonary Exacerbations of COPD
An observational study of Chronic Obstructive Pulmonary Disease (COPD), run by Strados Labs, Inc. at 2 sites in United States.
Trial summary
Listening to breath sounds with the 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 hospital. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- RESP Biosensor
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Mar 2023to 30 Dec 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 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects who are admitted to the hospital for exacerbation of COPD
Who may be able to join
- Males and females between the ages of 35 and 75 with documented physician-diagnosed COPD
- Hospitalization with a primary diagnosis of COPD with exacerbation or pneumonia.
- Patient able and willing to provide informed consent.
- Patient can follow study procedures, including instructions for self-placement and operation of device
- Patient has experience using a smartphone
- Accessible by telehealth/telephone upon discharge
- Patient is able and willing to return to study site for study follow-up visits as necessary
Who cannot join
- Patient unable or unwilling to provide informed consent
- Diagnosis of COPD is uncertain
- Plan for discharge to location other than the patient's home (eg, Nursing Home, Rehabilitation facility)
- Patient with end-stage medical condition with expected survival no more than 3 months
- History of adverse reaction or allergy to TegaDerm®
- Inaccessible by telehealth/telephone post discharge
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Albert Einstein Medical Center
Philadelphia, Pennsylvania, 19141
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19141
About this study
Official title: Utility of Remote Lung Auscultation in Transitions of Care After Pulmonary Exacerbations of Chronic Obstructive Pulmonary Disease
Listening to breath sounds with the 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 hospital. Of these, only auscultation routinely ceases upon discharge from Hospital. Healthcare utilization statistics have shown that for more than a decade, readmission after discharge for an exacerbation of COPD or severe asthma (or chronic heart failure) 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 spirometry
- Being tested
- RESP Biosensor
- 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.
RESP BiosensorDevice
Also called RESP
The RESP Biosensor will be placed on the patient for periodic recording of auscultory sound.
| Study group | Role | What they receive |
|---|---|---|
| Participants | Not described Receives: Device: RESP Biosensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Periodic recording over 24 hours for 30 days
Secondary outcomes (2)
Univariate and multivariate assessment of predictors of 30 day respiratory-disease specific hospital readmission rate
Measured: Periodic recording over 24 hours for 30 days
Univariate and multivariate assessment of predictors of 30 day total respiratory exacerbation rate (moderate + severe)
Measured: Periodic recording over 24 hours for 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2022
- Study start15 Mar 2023 (estimated)
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Why it stopped: Sponsor Hold
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Strados Labs, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05661435
- Sponsor's protocol ID
- SL-RS-TJUH01
- Status last verified
- Mar 2023
- First submitted
- 14 Dec 2022
- Last updated
- 16 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of Remote Lung Auscultation in Transitions of Care After Pulmonary Exacerbations of Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT05661435
- Acronym / sponsor ID
- SL-RS-TJUH01
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Sponsor Hold
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Strados Labs, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Mar 2023 (estimated)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 22 Dec 2022 (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.
Listening to breath sounds with the 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 hospital. Of these, only auscultation routinely ceases upon discharge from Hospital. Healthcare utilization statistics have shown that for more than a decade, readmission after discharge for an exacerbation of COPD or severe asthma (or chronic heart failure) 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 spirometry
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | – | Device: RESP Biosensor |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who are admitted to the hospital for exacerbation of COPD
Key inclusion criteria (7 listed)
- Males and females between the ages of 35 and 75 with documented physician-diagnosed COPD
- Hospitalization with a primary diagnosis of COPD with exacerbation or pneumonia.
- Patient able and willing to provide informed consent.
- Patient can follow study procedures, including instructions for self-placement and operation of device
- Accessible by telehealth/telephone upon discharge
Key exclusion criteria (6 listed)
- Patient unable or unwilling to provide informed consent
- Diagnosis of COPD is uncertain
- Plan for discharge to location other than the patient's home (eg, Nursing Home, Rehabilitation facility)
- Patient with end-stage medical condition with expected survival no more than 3 months
- History of adverse reaction or allergy to TegaDerm®
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 |
|---|---|---|
| RESP BiosensorAlso: RESPThe RESP Biosensor will be placed on the patient for periodic recording of auscultory sound. | Device | Participants |
Primary outcome
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
Time frame: Periodic recording over 24 hours for 30 days
2 secondary outcomes
Univariate and multivariate assessment of predictors of 30 day respiratory-disease specific hospital readmission rate
Time frame: Periodic recording over 24 hours for 30 days
Univariate and multivariate assessment of predictors of 30 day total respiratory exacerbation rate (moderate + severe)
Time frame: Periodic recording over 24 hours for 30 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2023.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease (COPD), run by Strados Labs, Inc. at 2 sites 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 7 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: withdrawn, as of the sponsor's last update on 16 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 withdrawn before enrolling participants, so there are no results.
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?
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 (time frame: Periodic recording over 24 hours for 30 days). 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 16 Mar 2023.