Voice Quality Analysis of Patients With Laryngotracheal Stenosis

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Idiopathic Subglottic Tracheal Stenosis
• Intervention / Treatment: Diagnostic test: Voice Biomarker Screening Too

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Samuel L Collins, Ph.D.; Phone Number: 4107020420; Email: scollin7@jh.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins Outpatient Center
      • Principal Investigator: Alexander Hillel, MD
      • Contact: Samuel L Collins, Ph.D.; Phone Number: 410-702-0420; Email: scollin7@jh.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Individuals with idiopathic subglottic stenosis

Description

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)

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Investigators: Principal Investigator: Alexander Hillel, MD, Johns Hopkins School of Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: November 29, 2023
• First Submitted That Met QC Criteria: November 29, 2023
• First Posted (Actual): December 7, 2023

Study Record Updates

• Last Update Posted (Actual): August 6, 2025
• Last Update Submitted That Met QC Criteria: August 1, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Voice Quality; Tracheal Stenosis
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Respiratory Tract Diseases; Tracheal Diseases; Constriction, Pathologic; Tracheal Stenosis
• Other Study ID Numbers: IRB00420355

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No