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NCT Number: NCT06389058

Using NLP and Neural Networks to Autonomously Identify Severe Asthma and Determine Study Eligibility in a Large Healthcare System

The study aims to to use new technologies (ML, AI, NLP), to autonomously identify moderate to severe asthma populations within an EHR system, describe differences in treatment patterns across different populations, and determine trial eligibility.

Primary Objectives Please ensure you detail primary objectives Aim 1. Determine and validate a diagnosis of severe asthma (SA) using predictive features obtained from the Scripps Health EHR.

* Aim 1a: Use ML applied to structured EHR data to predict SA. Use the opinion of 2 specialty-trained physicians and ATS guidelines to determine model accuracy. * Aim 1b: Use NLP applied to unstructured text to predict SA. Determine model accuracy as above in Aim 1a. * Aim 1c: Use a combination of ML applied to structured data to predict SA. Determine model accuracy as above in Aim 1a.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

6 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

San Diego State University

San Diego, California, 92182-1309, United States

About this study

Asthma is a heterogeneous disease. The heterogeneity of asthma is supported by clinical observations and genome wide association studies (GWASs) that have identified over 200 asthma susceptibility loci in the DNA. These genetic 'hot spots' are near inflammatory cytokines, growth factors, and other inflammatory proteins knowingly linked to airway inflammation, including cytokines IL-4, -5, -13, -25, -33, and TSLP.

Novel monoclonal antibody therapies have drastically changed the treatment of moderate-to-severe asthma. Novel monoclonal antibody therapies introduced in the last 7 years have greatly advanced treatment options for moderate-to-severe asthma patients. These therapies effectively reduce or eliminate severe exacerbations, prevent hospitalizations, and improve patients' quality of life. However, many severe asthma patients, particularly those living in underserved areas, are still being overtreated with steroids and undertreated with monoclonal antibodies.

The 21st Century Cures Act will Change the Landscape of Research. The 21st Century Cures Act reinforced the use of real-world data (RWD) and real-world evidence (RWE) to support clinical trials, aid in drug coverage decisions, develop national treatment guidelines as well as standardized decision support tools. An underutilized source of RWE/D are electronic health records (EHR). Machine Learning (ML), AI, and natural language processing (NLP) are developing technologies that will greatly advance our ability to leverage data in EHR systems.

The study aims to use new technologies (ML, AI, NLP), to autonomously identify moderate to severe asthma populations within an EHR system, describe differences in treatment patterns across different populations, and determine trial eligibility.

Primary Objectives Please ensure you detail primary objectives Aim 1. Determine and validate a diagnosis of severe asthma (SA) using predictive features obtained from the Scripps Health EHR.

  • Aim 1a: Use ML applied to structured EHR data to predict SA. Use the opinion of 2 specialty-trained physicians and ATS guidelines to determine model accuracy.
  • Aim 1b: Use NLP applied to unstructured text to predict SA. Determine model accuracy as above in Aim 1a.
  • Aim 1c: Use a combination of ML applied to structured data to predict SA. Determine model accuracy as above in Aim 1a.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Demographics: Males ~ 40%, Blacks ~ 5-10%, Hispanic ~15-30%, Urban ~80-90%

Exclusion criteria

  • None

Treatment and study plan

Recommendation for the diagnoses and treatment of Severe Asthma

Other

No intervention planned in this phase for the patients. Recommendations to be developed for healthcare and condition.

Primary outcomes

  1. Identification of Patients with Severe Asthma

    Time frame: 4 years

    Identify patients with severe asthma and compare diagnoses to that of medical professionals

Sponsors and collaborators

Lead sponsor

San Diego State University

Other

Collaborators

  • GlaxoSmithKline
  • Modena Allergy + Asthma, La Jolla, CA
  • Scripps Health
  • University of California, San Diego

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Apr 29, 2024
Registry last updated
Apr 22, 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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