Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06112080
Other study ID # SL-LC01
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 7, 2023
Est. completion date July 2024

Study information

Verified date November 2023
Source Strados Labs, Inc.
Contact Devan Parson
Phone 1-888-STRADOS
Email devan@stradoslabs.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 138
Est. completion date July 2024
Est. primary completion date July 2024
Accepts healthy volunteers
Gender All
Age group 4 Years to 17 Years
Eligibility 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


Intervention

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

Locations

Country Name City State
United States Lurie Children's Hospital of Chicago Chicago Illinois

Sponsors (1)

Lead Sponsor Collaborator
Strados Labs, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
See also
  Status Clinical Trial Phase
Completed NCT04624425 - Additional Effects of Segmental Breathing In Asthma N/A
Terminated NCT04410523 - Study of Efficacy and Safety of CSJ117 in Patients With Severe Uncontrolled Asthma Phase 2
Active, not recruiting NCT03927820 - A Pharmacist-Led Intervention to Increase Inhaler Access and Reduce Hospital Readmissions (PILLAR) N/A
Completed NCT04617015 - Defining and Treating Depression-related Asthma Early Phase 1
Recruiting NCT03694158 - Investigating Dupilumab's Effect in Asthma by Genotype Phase 4
Terminated NCT04946318 - Study of Safety of CSJ117 in Participants With Moderate to Severe Uncontrolled Asthma Phase 2
Completed NCT04450108 - Vivatmo Pro™ for Fractional Exhaled Nitric Oxide (FeNO) Monitoring in U.S. Asthmatic Patients N/A
Completed NCT03086460 - A Dose Ranging Study With CHF 1531 in Subjects With Asthma (FLASH) Phase 2
Completed NCT01160224 - Oral GW766944 (Oral CCR3 Antagonist) Phase 2
Completed NCT03186209 - Efficacy and Safety Study of Benralizumab in Patients With Uncontrolled Asthma on Medium to High Dose Inhaled Corticosteroid Plus LABA (MIRACLE) Phase 3
Completed NCT02502734 - Effect of Inhaled Fluticasone Furoate on Short-term Growth in Paediatric Subjects With Asthma Phase 3
Completed NCT01715844 - L-Citrulline Supplementation Pilot Study for Overweight Late Onset Asthmatics Phase 1
Terminated NCT04993443 - First-In-Human Study to Evaluate the Safety, Tolerability, Immunogenicity, and Pharmacokinetics of LQ036 Phase 1
Completed NCT02787863 - Clinical and Immunological Efficiency of Bacterial Vaccines at Adult Patients With Bronchopulmonary Pathology Phase 4
Recruiting NCT06033833 - Long-term Safety and Efficacy Evaluation of Subcutaneous Amlitelimab in Adult Participants With Moderate-to-severe Asthma Who Completed Treatment Period of Previous Amlitelimab Asthma Clinical Study Phase 2
Completed NCT03257995 - Pharmacodynamics, Safety, Tolerability, and Pharmacokinetics of Two Orally Inhaled Indacaterol Salts in Adult Subjects With Asthma. Phase 2
Completed NCT02212483 - Clinical Effectiveness and Economical Impact of Medical Indoor Environment Counselors Visiting Homes of Asthma Patients N/A
Recruiting NCT04872309 - MUlti-nuclear MR Imaging Investigation of Respiratory Disease-associated CHanges in Lung Physiology
Withdrawn NCT01468805 - Childhood Asthma Reduction Study N/A
Recruiting NCT05145894 - Differentiation of Asthma/COPD Exacerbation and Stable State Using Automated Lung Sound Analysis With LungPass Device