Idiopathic Subglottic Tracheal StenosisNCT06161077
Voice Quality Analysis of Patients With Laryngotracheal Stenosis
An observational study of Idiopathic Subglottic Tracheal Stenosis, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Idiopathic Subglottic Tracheal Stenosis
- What is being tested?
- Voice Biomarker Screening Too
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2027to 1 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
Study population: Individuals with idiopathic subglottic stenosis
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Johns Hopkins Outpatient Center
Baltimore, Maryland, 21287
Samuel L Collins, Ph.D., 410-702-0420, scollin7@jh.edu
Alexander Hillel, MD
About this study
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.
- Conditions
- Idiopathic Subglottic Tracheal Stenosis
- Being tested
- Voice Biomarker Screening Too
- Keywords
- Tracheal Stenosis, Voice Quality
- Medical subject headings
- Idiopathic subglottic tracheal stenosis, Tracheal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Voice Biomarker Screening TooDiagnostic test
The investigators will develop a screening tool using voice that can predict disease severity in idiopathic subglottic stenosis
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, 14 days, monthly for 2 years
Secondary outcomes (5)
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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 2 years or when surgical intervention is required if before 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2023
- Study start1 Jan 2027 (estimated)
- Primary completion1 Jan 2030 (estimated)
- Study completion1 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Subglottic Tracheal StenosisStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexander Hillel, MD, Principal investigator, Johns Hopkins School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06161077
- Sponsor's protocol ID
- IRB00420355
- Status last verified
- Jul 2026
- First submitted
- 29 Nov 2023
- Last updated
- 13 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Voice Quality Analysis of Patients With Laryngotracheal Stenosis
- ClinicalTrials.gov ID
- NCT06161077
- Acronym / sponsor ID
- IRB00420355
- Conditions
- Idiopathic Subglottic Tracheal Stenosis
- Keywords
- Tracheal Stenosis, Voice Quality
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 1 Jan 2030 (estimated)
- Study completion
- 1 Dec 2030 (estimated)
- First posted
- 7 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Individuals with idiopathic subglottic stenosis
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Voice Biomarker Screening TooThe investigators will develop a screening tool using voice that can predict disease severity in idiopathic subglottic stenosis | Diagnostic test | – |
Primary outcome
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
5 secondary outcomes
Change in Peak Expiratory flow (L/min) in patients with Laryngotracheal Stenosis
Time frame: Baseline, 14 days, monthly for 2 years
Change in Clinical COPD Questionnaire Quality of Life Score
Time frame: Baseline, 14 days, monthly for 2 years
Change in Eating Assessment Tool (EAT-10) Swallow Quality of Life Score
Time frame: Baseline, 14 days, monthly for 2 years
Change in 12-Item Short Form (SF-12) Survey Global Quality of Life Score
Time frame: Baseline, 14 days, monthly for 2 years
Change in lumen surface area
Time frame: 2 years or when surgical intervention is required if before 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
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RecruitingPhase 3
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alexander Hillel, MD principal investigator
Johns Hopkins School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Idiopathic Subglottic Tracheal Stenosis, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Samuel L Collins, Ph.D. (4107020420, scollin7@jh.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Voice Quality in patients with idiopathic subglottic stenosis (time frame: Baseline, 14 days, monthly for 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.