Development of Imaging Biomarkers for Voice After Pediatric Airway Reconstruction

Stopped early · Not applicable

Conditions studied: Voice Disorders

In brief

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.

Key facts

Study ID

NCT03076931

Run by

Children's Hospital Medical Center, Cincinnati

People needed

2

Starts

2016-08-01

Expected to finish

2019-10-15

Last updated by the study team

2021-02-09

Who can join

Age: 3 and older, up to 30. Sex: any. Healthy volunteers: accepted.

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
• Inclusion Criteria:
• 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.
• Exclusion Criteria:
• 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

Where it is running

• CCHMC — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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