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NCT Number: NCT06161077

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.

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Key information

Conditions

Idiopathic Subglottic Tracheal Stenosis Respiratory Tract Diseases Tracheal Diseases Tracheal Stenosis

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Johns Hopkins Outpatient Center

Baltimore, Maryland, 21287, United States

Location contact

Alexander Hillel, MD

PRINCIPAL_INVESTIGATOR

Samuel L Collins, Ph.D.

CONTACT

[email protected]

410-702-0420

Who can participate

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Voice Biomarker Screening Too

Diagnostic Test

The investigators will develop a screening tool using voice that can predict disease severity in idiopathic subglottic stenosis

Primary outcomes

  1. Voice Quality in patients with idiopathic subglottic stenosis

    Time frame: 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 outcomes

  1. Change in Peak Expiratory flow (L/min) in patients with Laryngotracheal Stenosis

    Time frame: Baseline, 14 days, monthly for 2 years

    Change in Peak Expiratory flow (L/min) in patients with Laryngotracheal Stenosis will be assessed.

  2. Change in Clinical COPD Questionnaire Quality of Life Score

    Time frame: Baseline, 14 days, monthly for 2 years

    Clinical COPD Questionnaire Quality of Life Score range of 0-6, with higher score indicating worse outcome

  3. Change in Eating Assessment Tool (EAT-10) Swallow Quality of Life Score

    Time frame: 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

  4. Change in 12-Item Short Form (SF-12) Survey Global Quality of Life Score

    Time frame: 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

  5. Change in lumen surface area

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Samuel L Collins, Ph.D.

CONTACT

[email protected]

4107020420

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Important dates

Study start
2027
Primary completion
2030
Study completion
2030
First posted
Dec 7, 2023
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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