About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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 population
Individuals with idiopathic subglottic stenosis
Trial design
Cohort
Prospective
Treatments tested in this trial
Voice Biomarker Screening Too
Diagnostic testThe investigators will develop a screening tool using voice that can predict disease severity in idiopathic subglottic stenosis
Treatment groups
Trial outcomes
Primary outcomes
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
Secondary outcomes
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.
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
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
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
Sponsors and contacts
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