Wearable Auscultation Device Validation in Children

Stopped early

Conditions studied: Asthma, Asthma in Children, Wheezing, Pediatric Asthma

In brief

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.

Key facts

Study ID

NCT06112080

Run by

Strados Labs, Inc.

People needed

36

Starts

2023-08-07

Expected to finish

2024-06-24

Last updated by the study team

2024-07-05

Who can join

Age: 4 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Lurie Children's Hospital of Chicago — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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