Development of Imaging Biomarkers for Voice After Pediatric Airway Reconstruction
Public ClinicalTrials.gov record NCT03076931. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Objective: The purpose of this proposal is to use High Speed Videoendoscopy (HSV) to develop and test an imaging biomarker to support diagnosis and predict vibratory outcome after airway reconstruction. Our protocol will involve eliciting and recording the following five behaviors: (1) hard throat clear; (2) cough; (3) laugh; (4) short multiple phonations; and (5) sustained phonation. These HSV recordings will be used to develop the biomarkers. Study Design: A prospective cohort study of 60 patients, 36 who will undergo airway reconstruction and 24 age matched controls. Setting: Center for Pediatric Voice Disorders, Department of Otolaryngology, Cincinnati Children's Hospital Medical Center Methods: Subjects will undergo a full voice evaluation, including an HSV evaluation protocol, at the main study site prior to airway reconstruction, 6 months post and 1 year post surgery. Voice evaluation will include aerodynamic, acoustic, and perceptual voice assessments, a pediatric voice handicap index questionnaire, videostroboscopy, and HSV. The airway evaluation will include airway sizing and calibration.
Study identification
- NCT ID
- NCT03076931
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 2 participants
Conditions and interventions
Conditions
Interventions
- Microlaryngoscopy Procedure
- Voice Evaluation Procedure
- Airway Reconstruction Procedure
Procedure
Eligibility (public fields only)
- Age range
- 3 Years to 30 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 31, 2016
- Primary completion
- Oct 14, 2019
- Completion
- Oct 14, 2019
- Last update posted
- Feb 8, 2021
2016 – 2019
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| CCHMC | Cincinnati | Ohio | 45229 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03076931, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 8, 2021 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03076931 live on ClinicalTrials.gov.