Idiopathic Subglottic Tracheal Stenosis
Conditions
Keywords
Tracheal Stenosis, Voice Quality
Brief summary
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_TESTVoice Biomarker Screening Too
The investigators will develop a screening tool using voice that can predict disease severity in idiopathic subglottic stenosis
Sponsors
Johns Hopkins University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Voice Quality in patients with idiopathic subglottic stenosis | Baseline, 14 days, monthly for 2 years | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Peak Expiratory flow (L/min) in patients with Laryngotracheal Stenosis | Baseline, 14 days, monthly for 2 years | Change in Peak Expiratory flow (L/min) in patients with Laryngotracheal Stenosis will be assessed. |
| Change in Clinical COPD Questionnaire Quality of Life Score | Baseline, 14 days, monthly for 2 years | 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 | Baseline, 14 days, monthly for 2 years | 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 | Baseline, 14 days, monthly for 2 years | 12-Item Short Form (SF-12) Survey Global Quality of Life Score of 0-100, with lower score indicating worse outcome |
| Change in lumen surface area | 2 years or when surgical intervention is required if before 2 years | CT Neck will be used to assess change in lumen surface area in millimeters squared |
Countries
United States
Contacts
CONTACTSamuel L Collins, Ph.D.
PRINCIPAL_INVESTIGATORAlexander Hillel, MD
Johns Hopkins School of Medicine
Outcome results
None listed