Voice Quality Analysis of Patients With Laryngotracheal Stenosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Voice Biomarker Screening Too.
- Who it may be relevant to
- Registry conditions: Idiopathic Subglottic Tracheal Stenosis. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Diagnostic test Voice Biomarker Screening Too
The investigators will develop a screening tool using voice that can predict disease severity in idiopathic subglottic stenosis
Primary outcome measures
- Voice Quality in patients with idiopathic subglottic stenosis [Time frame: Baseline, 14 days, monthly for 2 years]
Secondary outcome measures (5)
- Change in Peak Expiratory flow (L/min) in patients with Laryngotracheal Stenosis [Time frame: Baseline, 14 days, monthly for 2 years]
- Change in Clinical COPD Questionnaire Quality of Life Score [Time frame: Baseline, 14 days, monthly for 2 years]
- Change in Eating Assessment Tool (EAT-10) Swallow Quality of Life Score [Time frame: Baseline, 14 days, monthly for 2 years]
- Change in 12-Item Short Form (SF-12) Survey Global Quality of Life Score [Time frame: Baseline, 14 days, monthly for 2 years]
- Change in lumen surface area [Time frame: 2 years or when surgical intervention is required if before 2 years]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Johns Hopkins Outpatient Center — Baltimore
Identifiers
NCT: NCT06161077 · IRB00420355