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NCT Number: NCT02932176

Machine Learning for Handheld Vascular Studies

The use of handheld arterial 'stethoscopes' (continuous wave Doppler devices) are ubiquitous in clinical practice. However, most users have received no formal training in their use or the interpretation of the returned data. This leads to delays in diagnosis and errors in diagnosis.

The investigators intend to create a novel machine-learning algorithm to assist clinicians in the use of this data. This study will allow the investigators to collect sound files from the use of the devices and compare the algorithms output to established, existing vascular testing. There will be no invasive procedures, and use of these stethoscopes is part of routine clinical care.

If successful, this data and algorithm will be later deployed via smartphone app for point of case testing in a separate study

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location status: Recruiting

Location contact

Leila Mureebe, MD

CONTACT

[email protected]

About this study

There are three main research tasks for this project: 1) the identification of discriminant features of Doppler audio for patient classification, 2) the selection and training of classification algorithms, and 3) CWD audio data enrichment using physics-based models. The investigators will determine which discriminant features are optimal for patient classification from ultrasound Doppler audio.

To this end, the investigators will employ signal features in the frequency domain such as bandwidth, peak frequency, mean power, mean frequency, and time harmonic distortion, among others.

Furthermore, the investigators will investigate whether time domain features are necessary for accurate sound classification. Other studies have shown that specific features of audio waveforms can classify the data. The investigators will employ some of the most effective machine-learning algorithms for classification such as SVM, logistic regression, and Naïve Bayes, among others. The investigators will start with a binary classification problem in which individuals will be classified as healthy or unhealthy. Then, the investigators will move in complexity to multi-class classification problems in which individuals will be categorized into different groups according to defined abnormal arterial conditions. Data enrichment using physics-based models employing physiologically accurate finite element models of fluid flow in arteries to generate synthetic sound signals corresponding to various arterial conditions. Physics-based simulations would allow the investigators to produce a wealth of training data that can span many known arterial conditions. This capability can augment the classification accuracy and generalization of our algorithms, as clinical data may not be exhaustive enough to incorporate all the known arterial conditions. The investigators will study the performance of the trained algorithms on patient data. To this end, the investigators will partition the data into training and testing samples. The training samples will be used for training of the algorithms, while the testing set will be used to assess generalization capability. The investigators will compute misclassification rates for each algorithm as a metric for performance.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • A clinically driven request for non-invasive vascular testing must be present

Exclusion criteria

  • None (other than patient declines to participate)

Treatment and study plan

Non-invasive vascular testing

Device

Results of clinically indicated non-invasive vascular testing will be used to develop a machine learning algorithm

Other names: Continuous wave Doppler, plethysmography

machine-learning algorithm

Device

Primary outcomes

  1. Algorithm generated Doppler classification

    Time frame: 1 year

Secondary outcomes

  1. Presence or absence of pulse

    Time frame: 1 year

  2. Quality of pulse

    Time frame: 1 year

  3. Presence or absence of Doppler signal

    Time frame: 1 year

  4. Quality of Doppler signal

    Time frame: 1 year

Study contacts

Contact information is provided by the study sponsor or research team.

Leila Mureebe, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

Development and Validation of a Novel Machine-learning Algorithm to Assist in Handheld Vascular Diagnostics

Acronym: DopplerZAM

Important dates

Study start
2016
Primary completion
2026
Study completion
2026
First posted
Oct 13, 2016
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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