Skip to content

Feasibility of AI-based Classification of Normal, Wheeze and Crackle Sounds From Stethoscope in Clinical Settings

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05268263
Enrollment
60
Registered
2022-03-07
Start date
2022-01-06
Completion date
2022-02-22
Last updated
2023-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung, Respiratory

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.

Interventions

The enrolled population will include patients with a history of lung pathologies. Artificial intelligence-based models are developed for classification of wheezes, crackles and normal lung sounds. These AI models will be tested and assessed on local lung sounds clinical data.

Sponsors

Lady Reading Hospital, Pakistan
CollaboratorOTHER_GOV
NOABIO LLC
CollaboratorUNKNOWN
Innova Smart Technologies (Pvt.) Ltd
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

* Ages all * Written consent provided

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Testing the accuracy of artificial intelligence models for detection of wheeze, crackles, and normal lung sounds by measuring the sensitivity and specificity2 monthsArtificial 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
Clinical validation of AI models for detection of wheeze, crackles, and normal lung sounds by comparison with gold standard2 monthsAI 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

Secondary

MeasureTime frameDescription
Performance analysis of three digital stethoscopes: Littmann, NoaScope, and eSteth2 monthsPerformance analysis of three digital stethoscopes NoaScope, eSteth, and Littmann will be evaluated using the sensitivity and specificity achieved by each stethoscope. 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

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026