Wearable Auscultation Device Validation in Children

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 Overview

• Status: Recruiting
• Conditions: Asthma; Asthma in Children; Wheezing; Pediatric Asthma
• Intervention / Treatment: Device: RESP™ Biosensor

• Study Type: Observational
• Enrollment (Estimated): 138

Contacts and Locations

• Study Contact: Name: Devan Parson; Phone Number: 1-888-STRADOS; Email: devan@stradoslabs.com

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Lurie Children's Hospital of Chicago
      • Contact: Christian Johnson; Email: chrmjohnson@luriechildrens.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

pediatric subjects who present to Lurie Children's Hospital with or without wheezing.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Device: RESP™ Biosensor; The RESP™ Biosensor will be placed on all participants for immediate capture and comparison of lung sounds.; Other Names: Remote Electronic Stethoscope Platform
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	Device: RESP™ Biosensor; The RESP™ Biosensor will be placed on all participants for immediate capture and comparison of lung sounds.; Other Names: Remote Electronic Stethoscope Platform

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	12 months

Collaborators and Investigators

• Sponsor: Strados Labs, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 7, 2023
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: October 23, 2023
• First Submitted That Met QC Criteria: October 26, 2023
• First Posted (Actual): November 1, 2023

Study Record Updates

• Last Update Posted (Actual): November 13, 2023
• Last Update Submitted That Met QC Criteria: November 10, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Signs and Symptoms, Respiratory; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Respiratory Sounds
• Other Study ID Numbers: SL-LC01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes