Wearable Auscultation Device Validation in Children

Strados Labs

Status: Terminated

Conditions: Wheezing; Pediatric Asthma; Asthma; Asthma in Children

Treatments: Device: RESP™ Biosensor

Study type: Observational

Funder types: Industry

Identifiers

NCT06112080

SL-LC01

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 4 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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 design

36 participants in 2 patient groups

Normal Breath Sound Cohort

Description:

32 patients ages 4-10, 16 patients ages 11-17) * Admitted for a non-respiratory complaint * Normal breath sounds on screening examination

Treatment:

Device: RESP™ Biosensor

Wheeze Cohort

Description:

(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

Treatment:

Device: RESP™ Biosensor