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Clinical Trials/NCT05268263
NCT05268263
Completed
Not Applicable

Evaluating the Feasibility of Artificial Intelligence Algorithms in Clinical Settings for Classification of Normal, Wheeze and Crackle Sounds Acquired From a Digital Stethoscope

Innova Smart Technologies (Pvt.) Ltd1 site in 1 country60 target enrollmentJanuary 6, 2022
ConditionsRespiratoryLung

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Respiratory
Sponsor
Innova Smart Technologies (Pvt.) Ltd
Enrollment
60
Locations
1
Primary Endpoint
Clinical validation of AI models for detection of wheeze, crackles, and normal lung sounds by comparison with gold standard
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

Assessing the feasibility and testing the accuracy of the developed artificial intelligence algorithms for detection of wheezes and crackles in patients with lung pathologies in clinical settings on unseen local patient data acquired through three digital stethoscopes.

Registry
clinicaltrials.gov
Start Date
January 6, 2022
End Date
February 22, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Innova Smart Technologies (Pvt.) Ltd
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Written consent provided

Exclusion Criteria

  • Subject condition unstable
  • Chest wall deformity or wounds in adhesive application areas
  • Written consent not provided

Outcomes

Primary Outcomes

Clinical validation of AI models for detection of wheeze, crackles, and normal lung sounds by comparison with gold standard

Time Frame: 2 months

AI models will be tested for their clinical feasibility through comparison of results obtained from AI models with that of the gold standard by measuring positive and negative agreement (NPA \& PPA). The gold standard is the label given to each lung sound recording by an experienced consultant pulmonologist. The AI model is blinded to these labels and is tested independently for detection of normal lung sounds, wheezes, and crackles

Testing the accuracy of artificial intelligence models for detection of wheeze, crackles, and normal lung sounds by measuring the sensitivity and specificity

Time Frame: 2 months

Artificial intelligence models are trained on lung sounds collected from three different digital stethoscopes named NoaScope, eSteth, and Littmann individually. Data from all three digital stethoscopes is also merged to train separate AI models. These trained AI models will be evaluated based on sensitivity which is the ability to correctly identify wheezes and crackles, and specificity which is the ability to correctly identify normal lung sounds. True positive (TP), true negative (TN), false positive (FP), and false-negative (FN) values will be used to calculate sensitivity \& specificity using the following expressions. Sensitivity: TP/TP+FN Specificity: TN/TN+FP

Secondary Outcomes

  • Performance analysis of three digital stethoscopes: Littmann, NoaScope, and eSteth(2 months)

Study Sites (1)

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