AsthmaNCT06112080
Wearable Auscultation Device Validation in Children
An observational study of Asthma and Asthma in Children, run by Strados Labs, Inc. at 1 site in United States.
Trial summary
This observational clinical study is an evaluation of a diagnostic tool through comparison. Similar to a validation study, the output of the RESP device will be compared to physician auscultation, surrogated by having an attending pulmonologist listen to blinded recordings. Read more about this study
- Who is it for?
- Ages 4 to 17 years
- Conditions the study is for
- Asthma, Asthma in Children, Wheezing
- What is being tested?
- RESP™ Biosensor
- Type of treatment
- Medical device
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Aug 2023to 24 Jun 2024
- 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 4 to 17 years
- All sexes
- Child
Study population: pediatric subjects who present to Lurie Children's Hospital with or without wheezing.
Who may be able to join
- Any child aged 4-17 years of age
- Admitted to Lurie Children's Hospital or the Emergency Department at Lurie
- Normal breath sounds cohort: (16 patients ages 4-10, 16 patients ages 11-17)
- Admitted for a non-respiratory complaint
- Normal breath sounds on screening examination
- Wheeze cohort: (53 patients ages 4-10, 53 patients ages 11-17)
- Admitted for pathologic process that may lead to wheezing (e.g., asthma)
- Presence of wheeze on screening examination
Who cannot join
- Children less than age 4, adults (age 18 and above)
- Patients in the ambulatory setting
- Unable to provide consent
- Intubated patients
- Unstable disease posing a threat to life
- Adhesive allergy
Trial locations and contacts
1 site in 1 country.
United States1 site
Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
About this study
This observational clinical study is an evaluation of a diagnostic tool through comparison. Similar to a validation study, the output of the RESP device will be compared to physician auscultation, surrogated by having an attending pulmonologist listen to blinded recordings.
- Conditions
- Asthma, Asthma in Children, Wheezing, Pediatric Asthma
- Being tested
- RESP™ Biosensor
- Medical subject headings
- Asthma, Respiratory Sounds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RESP™ BiosensorDevice
Also called Remote Electronic Stethoscope Platform
The RESP™ Biosensor will be placed on all participants for immediate capture and comparison of lung sounds.
| Study group | Role | What they receive |
|---|---|---|
| Normal Breath Sound Cohort | 32 patients ages 4-10, 16 patients ages 11-17)
* Admitted for a non-respiratory complaint
* Normal breath sounds on screening examination Receives: Device: RESP™ Biosensor | |
| Wheeze Cohort | (106 patients ages 4-10, 53 patients ages 11-17)
* Admitted for pathologic process that may lead to wheezing (e.g., asthma)
* Presence of wheeze on screening examination Receives: Device: RESP™ Biosensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the output of the RESP Biosensor System to breath sound interpretation of an attending physician via collected recordings from stethoscope and completion of a comparison questionnaire
PI will compare Strados RESP portal output with concurrent recordings collected via Littmann 300 Stethoscope. A questionnaire will be used to record and determine similarities and differences between RESP output and Littmann output, ultimately validating the intended use. Spectrographic data and audio recordings obtained via auscultation will be collected respectively by the RESP device and a separate recording stethoscope (Littman CORE Digital Stethoscope) simultaneously. Demographic and clinical data will be collected and stored in REDcap.
Measured: 12 months
Secondary outcomes (1)
Tolerability and usability assessed utilizing The System Usibility Scale to evaluate attitudes towards the use and tolerance of the device by patients and caregivers
Assess the tolerability and usability of the Strados device by patients and caregivers utilizing the System Usability Scale will be used to evaluate subjects and caregivers attitudes towards the use and tolerance of the device. The System Usability Scale is a validated tool for evaluation of the usability and tolerability of a device or system by users. Then, subjects and caregivers will engage in a recorded interview using talk-aloud feedback. Recorded data will be transcribed and evaluated through quality analysis
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2023
- Study start7 Aug 2023
- Primary completion24 Jun 2024
- Study completion24 Jun 2024
Why it stopped: The Principal Investigator is departing from the study site.
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 36 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
- NCT06112080
- Sponsor's protocol ID
- SL-LC01
- Status last verified
- Nov 2023
- First submitted
- 23 Oct 2023
- Last updated
- 5 Jul 2024
- 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 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wearable Auscultation Device Validation in Children
- ClinicalTrials.gov ID
- NCT06112080
- Acronym / sponsor ID
- SL-LC01
- Conditions
- Asthma, Asthma in Children, Wheezing, Pediatric Asthma
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The Principal Investigator is departing from the study site.
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Strados Labs, Inc.Industry (pharma, biotech, devices)
- Study start
- 7 Aug 2023 (actual)
- Primary completion
- 24 Jun 2024 (actual)
- Study completion
- 24 Jun 2024 (actual)
- First posted
- 1 Nov 2023 (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 observational clinical study is an evaluation of a diagnostic tool through comparison. Similar to a validation study, the output of the RESP device will be compared to physician auscultation, surrogated by having an attending pulmonologist listen to blinded recordings.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal Breath Sound Cohort | – | Device: RESP™ Biosensor32 patients ages 4-10, 16 patients ages 11-17) * Admitted for a non-respiratory complaint * Normal breath sounds on screening examination |
| Wheeze Cohort | – | Device: RESP™ Biosensor(106 patients ages 4-10, 53 patients ages 11-17) * Admitted for pathologic process that may lead to wheezing (e.g., asthma) * Presence of wheeze on screening examination |
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Age groups
- Child
- Study population
- pediatric subjects who present to Lurie Children's Hospital with or without wheezing.
Key inclusion criteria (8 listed)
- Any child aged 4-17 years of age
- Admitted to Lurie Children's Hospital or the Emergency Department at Lurie
- Normal breath sounds cohort: (16 patients ages 4-10, 16 patients ages 11-17)
- Wheeze cohort: (53 patients ages 4-10, 53 patients ages 11-17)
Key exclusion criteria (6 listed)
- Children less than age 4, adults (age 18 and above)
- Patients in the ambulatory setting
- Unable to provide consent
- Intubated patients
- Unstable disease posing a threat to life
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: Remote Electronic Stethoscope PlatformThe RESP™ Biosensor will be placed on all participants for immediate capture and comparison of lung sounds. | Device | Normal Breath Sound Cohort, Wheeze Cohort |
Primary outcome
Compare the output of the RESP Biosensor System to breath sound interpretation of an attending physician via collected recordings from stethoscope and completion of a comparison questionnaire
Time frame: 12 months
PI will compare Strados RESP portal output with concurrent recordings collected via Littmann 300 Stethoscope. A questionnaire will be used to record and determine similarities and differences between RESP output and Littmann output, ultimately validating the intended use. Spectrographic data and audio recordings obtained via auscultation will be collected respectively by the RESP device and a separate recording stethoscope (Littman CORE Digital Stethoscope) simultaneously. Demographic and clinical data will be collected and stored in REDcap.
1 secondary outcome
Tolerability and usability assessed utilizing The System Usibility Scale to evaluate attitudes towards the use and tolerance of the device by patients and caregivers
Time frame: 12 months
Results and safety
The study was stopped early (reason given: The Principal Investigator is departing from the study site.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Asthma
RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
Cystic Fibrosis, Pulmonary Fibrosis
RecruitingObservational study
Study of the Effect of Innate on the Inflammatory Response to Endotoxin
Asthma, Atherosclerosis
Active, not recruitingPhase 2
A Dose Finding Study With an Anti-TSLP Antibody (GSK5784283) in Adults Aged 18 to 75 Years of Age With Uncontrolled Asthma
Asthma
Active, not recruiting
Technology-Enhanced Asthma Care in Children at Clinic and Home Study
Asthma in Children, Chronic Diseases in Children
Recruiting
Lungs on Fire: Wildfire Smoke, Incident Diseases, Susceptible Populations, and Community Values in Canada
Asthma, Chronic Obstructive Pulmonary Disease (COPD)
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.
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 Asthma and Asthma in Children, run by Strados 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 8 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 5 Jul 2024. 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: The Principal Investigator is departing from the study site.). 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?
Compare the output of the RESP Biosensor System to breath sound interpretation of an attending physician via collected recordings from stethoscope and completion of a comparison questionnaire (time frame: 12 months). 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 5 Jul 2024; AzTrials last refreshed its copy on 26 Oct 2026.