AsthmaNCT07792330
Asthma Lung Sounds With Wearable Stethoscope
A study testing Prototype Wearable Stethoscope in people with Asthma and Pediatric Asthma, run by Children's Hospital Los Angeles at 1 site in United States.
Trial summary
The goal of this clinical trial is to evaluate a prototype wearable stethoscope designed to record lung sounds and assess asthma control in children and adolescents with asthma aged 4 to 17 years who are able to perform spirometry. Read more about this study
- Who is it for?
- Ages 4 to 17 years
- Conditions the study is for
- Asthma, Pediatric Asthma, Airway Obstruction Upper
- What is being tested?
- Prototype Wearable Stethoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 4 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children and adolescents aged 4 to 17 years
- Diagnosis of asthma
- Ability to perform spirometry
- Assent (as applicable) and parental/legal guardian permission obtained
Who cannot join
- Unable to follow spirometry procedures
- Intubated at the time of enrollment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Children's Hospital Los Angeles
Los Angeles, California, 90027
Danny Del Cid-Linares, 3233611983, ddelcidlinares@chla.usc.edu
Roberta Kato, MD
About this study
The goal of this clinical trial is to evaluate a prototype wearable stethoscope designed to record lung sounds and assess asthma control in children and adolescents with asthma aged 4 to 17 years who are able to perform spirometry. The study aims to determine whether the prototype wearable stethoscope can accurately detect clinically meaningful changes in lung sounds associated with asthma control and response to bronchodilator treatment.
The main questions it aims to answer are:
Read more
- Does the prototype wearable stethoscope demonstrate agreement with recordings obtained from commercially available Thinklabs One Digital Stethoscopes in identifying normal and abnormal lung sounds?
- Are lung sounds detected by the prototype wearable stethoscope associated with asthma symptom control as measured by the Childhood Asthma Control Test (cACT) or Asthma Control Test (ACT)
Researchers will compare recordings obtained from the prototype wearable stethoscope with recordings obtained from FDA-cleared Thinklabs One Digital Stethoscopes to evaluate the prototype device's ability to detect abnormal lung sounds and changes in lung sounds following bronchodilator treatment.
- Conditions
- Asthma, Pediatric Asthma, Airway Obstruction Upper
- Being tested
- Prototype Wearable Stethoscope
- Keywords
- Wearable Stethoscope, Asthma, Lung Sound Monitoring
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prototype Wearable StethoscopeDevice
The Prototype Wearable Stethoscope is a wireless device used to record lung sounds in children with asthma. Recordings will be compared with a standard digital stethoscope to evaluate device performance.
| Study group | Role | What they receive |
|---|---|---|
| Prototype Wearable Stethoscope Evaluation | Experimental | Participants aged 4 to 17 years with asthma will complete asthma control questionnaires, undergo pre- and post-bronchodilator spirometry, and have lung sounds recorded simultaneously using a prototype wearable stethoscope and four Thinklabs One Digital Stethoscopes. Lung sound recordings obtained before and after bronchodilator administration will be used to evaluate agreement between devices and assess associations between detected lung sounds, lung function, and asthma control Receives: Device: Prototype Wearable Stethoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement Between Prototype Wearable Stethoscope and Thinklabs One Digital Stethoscope
Agreement between the prototype wearable stethoscope and the FDA-cleared Thinklabs One Digital Stethoscope in the classification of normal versus abnormal lung sounds, assessed using Cohen's Kappa.
Measured: Single study visit (up to 90 minutes).
Association Between Lung Sounds and Asthma Control Scores
Association between abnormal lung sounds detected by the prototype wearable stethoscope and asthma control as measured by the Childhood Asthma Control Test (cACT) or Asthma Control Test (ACT).
Measured: Single study visit (up to 90 minutes).
Secondary outcomes (4)
Sensitivity of Abnormal Lung Sound Detection
Sensitivity of the prototype wearable stethoscope for detecting abnormal lung sounds compared with Thinklabs One Digital Stethoscope recordings
Measured: Single study visit (up to 90 minutes).
Specificity of Abnormal Lung Sound Detection
Specificity of the prototype wearable stethoscope for detecting abnormal lung sounds compared with Thinklabs One Digital Stethoscope recordings
Measured: Single study visit (up to 90 minutes).
Positive Predictive Value (PPV)
Positive predictive value of the prototype wearable stethoscope for identifying abnormal lung sounds compared with Thinklabs One Digital Stethoscope recordings.
Measured: Single study visit (up to 90 minutes).
Negative Predictive Value (NPV)
Negative predictive value of the prototype wearable stethoscope for identifying abnormal lung sounds compared with Thinklabs One Digital Stethoscope recordings.
Measured: Single study visit (up to 90 minutes).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2026
- Study start1 Oct 2026 (estimated)
- Primary completion30 Jul 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), University of Southern California
- Responsible party
- Principal investigator, Roberta Kato, Children's Hospital Los Angeles
- Investigators
- Roberta Kato, MD, Principal investigator, Children's Hospital Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07792330
- Sponsor's protocol ID
- CHLA-25-00088
- Other IDs
- 5R01HL165138
- Status last verified
- Aug 2026
- First submitted
- 25 Aug 2026
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Asthma Lung Sounds With Wearable Stethoscope
- ClinicalTrials.gov ID
- NCT07792330
- Acronym / sponsor ID
- CHLA-25-00088
- Conditions
- Asthma, Pediatric Asthma, Airway Obstruction Upper
- Keywords
- Wearable Stethoscope, Asthma, Lung Sound Monitoring
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Children's Hospital Los AngelesUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), University of Southern California
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 28 Aug 2026 (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.
The goal of this clinical trial is to evaluate a prototype wearable stethoscope designed to record lung sounds and assess asthma control in children and adolescents with asthma aged 4 to 17 years who are able to perform spirometry. The study aims to determine whether the prototype wearable stethoscope can accurately detect clinically meaningful changes in lung sounds associated with asthma control and response to bronchodilator treatment.
The main questions it aims to answer are:
- Does the prototype wearable stethoscope demonstrate agreement with recordings obtained from commercially available Thinklabs One Digital Stethoscopes in identifying normal and abnormal lung sounds?
- Are lung sounds detected by the prototype wearable stethoscope associated with asthma symptom control as measured by the Childhood Asthma Control Test (cACT) or Asthma Control Test (ACT)
Researchers will compare recordings obtained from the prototype wearable stethoscope with recordings obtained from FDA-cleared Thinklabs One Digital Stethoscopes to evaluate the prototype device's ability to detect abnormal lung sounds and changes in lung sounds following bronchodilator treatment.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prototype Wearable Stethoscope Evaluation | Experimental | Device: Prototype Wearable StethoscopeParticipants aged 4 to 17 years with asthma will complete asthma control questionnaires, undergo pre- and post-bronchodilator spirometry, and have lung sounds recorded simultaneously using a prototype wearable stethoscope and four Thinklabs One Digital Stethoscopes. Lung sound recordings obtained before and after bronchodilator administration will be used to evaluate agreement between devices and assess associations between detected lung sounds, lung function, and asthma control |
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children and adolescents aged 4 to 17 years
- Diagnosis of asthma
- Ability to perform spirometry
- Assent (as applicable) and parental/legal guardian permission obtained
Key exclusion criteria (2 listed)
- Unable to follow spirometry procedures
- Intubated at the time of enrollment
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 |
|---|---|---|
| Prototype Wearable StethoscopeThe Prototype Wearable Stethoscope is a wireless device used to record lung sounds in children with asthma. Recordings will be compared with a standard digital stethoscope to evaluate device performance. | Device | Prototype Wearable Stethoscope Evaluation |
Primary outcome
Agreement Between Prototype Wearable Stethoscope and Thinklabs One Digital Stethoscope
Time frame: Single study visit (up to 90 minutes).
Agreement between the prototype wearable stethoscope and the FDA-cleared Thinklabs One Digital Stethoscope in the classification of normal versus abnormal lung sounds, assessed using Cohen's Kappa.
Association Between Lung Sounds and Asthma Control Scores
Time frame: Single study visit (up to 90 minutes).
Association between abnormal lung sounds detected by the prototype wearable stethoscope and asthma control as measured by the Childhood Asthma Control Test (cACT) or Asthma Control Test (ACT).
4 secondary outcomes
Sensitivity of Abnormal Lung Sound Detection
Time frame: Single study visit (up to 90 minutes).
Specificity of Abnormal Lung Sound Detection
Time frame: Single study visit (up to 90 minutes).
Positive Predictive Value (PPV)
Time frame: Single study visit (up to 90 minutes).
Negative Predictive Value (NPV)
Time frame: Single study visit (up to 90 minutes).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Individual participant dataSharing planned: No
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Asthma
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.
Roberta Kato, MD principal investigator
Children's Hospital Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prototype Wearable Stethoscope in people with Asthma and Pediatric Asthma, run by Children's Hospital Los Angeles 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 4 inclusion and 2 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: opening soon, as of the sponsor's last update on 28 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Danny Del Cid-Linares (310-445-0919, ddelcidlinares@chla.usc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement Between Prototype Wearable Stethoscope and Thinklabs One Digital Stethoscope (time frame: Single study visit (up to 90 minutes).). 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 28 Aug 2026.