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Voice Quality Analysis of Patients With Laryngotracheal Stenosis

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Johns Hopkins University

Status

Begins enrollment in 4 months

Conditions

Idiopathic Subglottic Tracheal Stenosis

Treatments

Diagnostic Test: Voice Biomarker Screening Too

Study type

Observational

Funder types

Other

Identifiers

NCT06161077
IRB00420355

Details and patient eligibility

About

The investigators previously demonstrated that voice changes are common in patients with Laryngotracheal Stenosis (LTS), and patients typically report an improvement in voice outcomes following endoscopic dilation. Recently, NIH based programs such as a Bridge to Artificial Intelligence (Bridge2AI) have highlighted the use of artificial intelligence to identify acoustic biomarkers of disease. Therefore, the investigators hypothesize that progression of LTS scar can be quantified using acoustic measurements and machine learning. The goal of this clinical trial is to remotely monitor patient voice quality in an effort to determine if regularly performed voice recordings can be used as a diagnostic tool in order to predict the need for dilation procedures. The investigators feel that successful use of remote voice recording technology with algorithmic analysis will improve patient quality of life.

Enrollment

100 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Current diagnosis of laryngotracheal stenosis
  • Patient age 18 - 80 years old
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1
  • The patient must be able to comprehend and have signed the informed consent.
  • The patient must have documentation of their date of laryngotracheal stenosis diagnosis and prior medical/surgical history.

Exclusion criteria

  • Inability to use the app associated with the study.
  • Comorbid laryngeal or glottic disease
  • Concurrent neurological disease which may impact voice use (such as tremor, parkinsonism, laryngeal dystonia)

Trial contacts and locations

1

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Central trial contact

Samuel L Collins, Ph.D.

Data sourced from clinicaltrials.gov

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