Wearable Auscultation Device Validation in Children

NCT06112080 | Terminated FDA Device

• 1 other identifier: SL-LC01
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma; Asthma in Children; Wheezing; Pediatric Asthma

Outcome Measures

Primary Outcomes (1)

• 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 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

  12 months

Study Arms (2)

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

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

Interventions

RESP™ Biosensor DEVICE

The RESP™ Biosensor will be placed on all participants for immediate capture and comparison of lung sounds.

Also known as: Remote Electronic Stethoscope Platform

Normal Breath Sound Cohort; Wheeze Cohort

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

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

Sponsors & Collaborators

• Strados Labs, Inc.: lead

Study Sites (1)

Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Asthma; Respiratory Sounds

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2023
• First Posted: November 1, 2023
• Study Start: August 7, 2023
• Primary Completion: June 24, 2024
• Study Completion: June 24, 2024
• Last Updated: July 5, 2024

Record last verified: 2023-11

Locations

US (1)