Voice Quality Analysis of Patients With Laryngotracheal Stenosis

Study Overview
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Brief Summary
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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.

Official Title
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Voice Quality Analysis of Patients With Laryngotracheal Stenosis

Conditions
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Idiopathic Subglottic Tracheal Stenosis

Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Voice Quality in patients with idiopathic subglottic stenosis | To remotely assess voice quality of patients with idiopathic subglottic stenosis with VoiceLab automated voice analysis software both before and at regular intervals following dilation procedures | Baseline, 14 days, monthly for 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Peak Expiratory flow (L/min) in patients with Laryngotracheal Stenosis | Change in Peak Expiratory flow (L/min) in patients with Laryngotracheal Stenosis will be assessed. | Baseline, 14 days, monthly for 2 years | 
| Change in Clinical COPD Questionnaire Quality of Life Score | Clinical COPD Questionnaire Quality of Life Score range of 0-6, with higher score indicating worse outcome | Baseline, 14 days, monthly for 2 years | 
| Change in Eating Assessment Tool (EAT-10) Swallow Quality of Life Score | Eating Assessment Tool (EAT-10) Swallow Quality of Life Score range of 0-40, with higher score indicating worse outcome | Baseline, 14 days, monthly for 2 years | 
| Change in 12-Item Short Form (SF-12) Survey Global Quality of Life Score | 12-Item Short Form (SF-12) Survey Global Quality of Life Score of 0-100, with lower score indicating worse outcome | Baseline, 14 days, monthly for 2 years | 
| Change in lumen surface area | CT Neck will be used to assess change in lumen surface area in millimeters squared | 2 years or when surgical intervention is required if before 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Voice Quality, Tracheal Stenosis