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Wearable Auscultation Device Validation in Children | Clinical Trials | Clareo Health

TERMINATED

Wearable Auscultation Device Validation in Children

NCT06112080•Strados Labs, Inc.

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.

Eligibility

Age

4 - 17 years

Sex

ALL

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

Locations (1)

Lurie Children's Hospital of Chicago

Chicago, Illinois, United States

Key Dates

Start Date

August 7, 2023

Primary Completion Date

June 24, 2024

Completion Date

June 24, 2024

Last Updated

July 5, 2024

Enrollment

ACTUAL participants

Conditions

AsthmaAsthma in ChildrenWheezingPediatric Asthma

Interventions

RESP™ Biosensor

DEVICE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 5, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Wearable Auscultation Device Validation in Children

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma

NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)

Blood Eosinophil Guided Versus Usual Care In The Management Of Mild To Moderate Asthma at Primary Care (BEAM)

Relationship of Airway Microbiota, Endotype and Phenotype in Adult Asthma

To Assess the Management of Patients on Global Initiative of Asthma (GINA) Step 4 and 5 Treatment in Hong Kong

A Study to Investigate Efficacy and Safety of PT027 Compared With PT007 in Symptomatic Chinese Adults With Asthma