Development of Imaging Biomarkers for Voice After Pediatric Airway Reconstruction

NCT03076931 | Terminated

• 1 other identifier: 2016-2378
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Voice Disorders

Keywords

Voice; Biomarker; Airway Reconstruction

Outcome Measures

Primary Outcomes (1)

• Identification of Patient's Vibratory Source

  Vibratory source will be rated by having HSV imaging samples subjected to an automatic temporal segmentation, which will extract the HSV segment of interest. The extracted temporal segment (i.e. token) is subjected to an automatic image segmentation based on the oscillating edges of the anatomic structures using kymographic paired active contours. The image segmentation will be aided by an automatic spectral oscillation analysis similar to previously published methods. Three raters will be asked to interpret the image analysis results, which will be overlaid on the HSV image. To identify the patient's vibratory source, among the segmented vibratory areas, the raters will identify which vibratory structure(s)--glottis, false vocal folds, aryepiglottic folds, arytenoid against epiglottis, other supraglottal structures, or any combination of those--could be phonatory/which anatomic structure produced the vibration.

  Up to One Year

Secondary Outcomes (6)

• Tissue Health of Patient--Vocal Fold Vibration

  Up to One Year

• Tissue Health of Patient--Scarring of Airway

  Up to One Year

• Maximum Adduction

  Up to One Year

• Maximum Abduction

  Up to One Year

• Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V)

  Up to One Year

Study Arms (2)

Study: Airway Reconstruction Patients

EXPERIMENTAL

These participants have significant airway abnormalities that require invasive surgery, such as Laryngotracheoplasty, to rectify, and whose voice quality may suffer as a result of the surgery. The goal of this study is to improve voice outcomes of these patients, and their clinical data will be collected.

Procedure: Microlaryngoscopy; Procedure: Voice Evaluation; Procedure: Airway Reconstruction

Control: Normal Airway Patients

EXPERIMENTAL

These participants have normal airways and voice who will undergo a microlaryngoscopy and voice evaluation, the data from which will be compared to study patients.

Procedure: Microlaryngoscopy; Procedure: Voice Evaluation

Interventions

Microlaryngoscopy PROCEDURE

Standard clinical procedure, used to perform airway sizing and vocal fold calibration. Controls receive one as a research procedure, while study patients receive one as part of standard of care.

Also known as: MLB

Control: Normal Airway Patients; Study: Airway Reconstruction Patients

Voice Evaluation PROCEDURE

Standard clinical procedure that includes aerodynamic, acoustic, and perceptual voice assessments, a pediatric voice handicap index questionnaire, videostroboscopy, and high-speed videoendoscopy. Controls will receive one as a research procedure, while study patients will receive three, one before their airway reconstruction, and two more in the year afterward, as part of standard of care.

Control: Normal Airway Patients; Study: Airway Reconstruction Patients

Airway Reconstruction PROCEDURE

This includes many types of invasive surgical procedures such as Laryngotracheoplasty to repair a patient's compromised airway. Only study patients will be receiving one, and it will be as part of standard of care unrelated to this study, but the data from surgery and outcomes being pertinent to the study.

Study: Airway Reconstruction Patients

Eligibility Criteria

• Age: 3 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Ages of 3-30 years,
• No prior airway surgery
• Able to undergo the evaluation protocol

You may not qualify if:

• ) Patients who have undergone any prior airway reconstruction and/or have a disability that precludes them from completing the evaluation
• Control Patients
• Age of 3-30 years
• No prior history of intubation injury or airway/laryngeal surgery
• Normal hearing
• Normal voice assessment performed by a certified speech-language pathologist 5.) Undergoing a non-airway surgical procedure such as adenoidectomy, tonsillectomy, ear tubes, and neck mass removal.
• Has had airway or laryngeal surgery
• History of a voice or hearing disorder
• History of neonatal intubation over 14 days
• Have a disability that precludes them from completing the evaluation

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• Triological Society: collaborator

Study Sites (1)

CCHMC

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Voice Disorders

Condition Hierarchy (Ancestors)

Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Alessandro de Alarcon, MD

  CCHMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2016
• First Posted: March 10, 2017
• Study Start: August 1, 2016
• Primary Completion: October 15, 2019
• Study Completion: October 15, 2019
• Last Updated: February 9, 2021

Record last verified: 2021-02

Locations

US (1)