Voice Quality Analysis of Patients With Laryngotracheal Stenosis

Not yet recruiting

• Conditions: Idiopathic Subglottic Tracheal Stenosis

• Registration Number: NCT06161077
• Lead Sponsor: Johns Hopkins University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-29
• Study First Submitted QC: 2023-11-29
• Study First Posted: 2023-12-07
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-16
• Last Update Posted: 2024-07-18
• Study Start: 2025-07-01
• Primary Completion: 2027-07-01
• Study Completion: 2027-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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 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

Trial Locations

Locations (1)

Johns Hopkins Outpatient Center; 🇺🇸 Baltimore, Maryland, United States