Wearable Auscultation Device Validation in Children

Terminated

• Conditions: Asthma in Children; Pediatric Asthma; Wheezing; Asthma
• Interventions: Device: RESP™ Biosensor

• Registration Number: NCT06112080
• Lead Sponsor: Strados Labs, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-07
• Study First Submitted: 2023-10-23
• Study First Submitted QC: 2023-10-26
• Status Verified: 2023-11
• Study First Posted: 2023-11-01
• Primary Completion: 2024-06-24
• Study Completion: 2024-06-24
• Last Update Submitted: 2024-07-02
• Last Update Posted: 2024-07-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Wheeze Cohort	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
Normal Breath Sound Cohort	RESP™ Biosensor	32 patients ages 4-10, 16 patients ages 11-17) * Admitted for a non-respiratory complaint * Normal breath sounds on screening examination

Primary Outcome Measures

Name	Time	Method
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	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.

Secondary Outcome Measures

Name	Time	Method
Tolerability and usability assessed utilizing The System Usibility Scale to evaluate attitudes towards the use and tolerance of the device by patients and caregivers	12 months	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

Trial Locations

Locations (1)

Lurie Children's Hospital of Chicago; 🇺🇸 Chicago, Illinois, United States