Clinical trial NCT06161077: Voice Quality Analysis of Patients With Laryngotracheal Stenosis
Official title: Voice Quality Analysis of Patients With Laryngotracheal Stenosis
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Idiopathic Subglottic Tracheal Stenosis
Keywords: Tracheal Stenosis
Voice Quality
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2023-12-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Individuals with idiopathic subglottic stenosis

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.


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)

Primary outcomes:
measure: Voice Quality in patients with idiopathic subglottic stenosis
timeFrame: Baseline, 14 days, monthly for 2 years
Secondary outcomes:
measure: Change in Peak Expiratory flow (L/min) in patients with Laryngotracheal Stenosis
timeFrame: Baseline, 14 days, monthly for 2 years
measure: Change in Clinical COPD Questionnaire Quality of Life Score
timeFrame: Baseline, 14 days, monthly for 2 years
measure: Change in Eating Assessment Tool (EAT-10) Swallow Quality of Life Score
timeFrame: Baseline, 14 days, monthly for 2 years
measure: Change in 12-Item Short Form (SF-12) Survey Global Quality of Life Score
timeFrame: Baseline, 14 days, monthly for 2 years
measure: Change in lumen surface area
timeFrame: 2 years or when surgical intervention is required if before 2 years
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Outpatient Center
state: Maryland
Study officials:
affiliation: Johns Hopkins School of Medicine
name: Alexander Hillel, MD
role: PRINCIPAL_INVESTIGATOR
References: