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Идёт набор NCT06975046

Aerodynamic Measurements in the Pediatric Population

Без фазы С лечением Normal Voice

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Complete airflow interruption, Incomplete airflow interruption, Airflow redirection.
Кому может быть актуально
Состояния в реестре: Normal Voice. Базовые параметры: 4 лет — 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Обзор

The goal of this clinical trial is to create a vocal health database of people aged 4-65 with no diagnosed voice pathology. The main question it aims to answer is: * what is the best way to assess pediatric voices; and, * what are the differences between healthy and dysphonic pediatric voices? Participants will complete one 60 minute session involving one of three types of aerodynamic interruption.

Подробное описание

The primary goals of this research are to develop noninvasive aerodynamic assessments specific to the pediatric population, and to describe differences between healthy and dysphonic pediatric voices between the ages of 4-17 years. An adult cohort (ages 18-65) will function as a comparison group for incomplete interruption. To account for challenges associated with pediatric data collection, we will modify our current devices and methods of aerodynamic assessment to be better suited for use with the pediatric population and aim to increase measurement reliability in younger subjects. Our proposed modifications include shorter trial times, auditory masking, the use of cheek restraints, and gamification.

After identification of optimal data collection conditions for each method, we will compare these in a large group of children with normal voice. These data will be compared to data from children with vocal fold nodules or polyp. All data will be compiled into a pediatric vocal health database.

Вмешательства

  • Устройство Complete airflow interruption
    Participants will produce a sustained vowel into a mouthpiece (with nose-clip) connected to a PVC tube, with a balloon valve
  • Устройство Incomplete airflow interruption
    Incomplete airflow interruption uses a Y-shaped device. The participant produces a sustained /a/ into a mouthpiece and air filter connected to the tube. The tube splits into two tubes distally.
  • Устройство Airflow redirection
    Participant phonates through a mouthpiece into a PVC tube that splits into two paths. One path is connected to an open balloon valve. When the balloon is inflated and blocks the path, air is redirected into the other path which is gated by a one-way valve.

Первичные конечные точки

  • Compare subglottic pressure across different airflow interruption methods [Срок оценки: 60 minutes]
  • Compare phonation threshold pressure (PTP) across airflow interruption methods [Срок оценки: 60 minutes]
  • Compare laryngeal resistance across airflow interruption methods [Срок оценки: 90 minutes]
  • Compare subglottic pressure between benign vocal fold lesions and normal voices [Срок оценки: 90 minutes]
  • Compare PTP between benign vocal fold lesions and normal voices [Срок оценки: 90 minutes]
  • Compare laryngeal resistance between benign vocal fold lesions and normal voices [Срок оценки: 90 minutes]
  • Compare vocal efficiency between benign vocal fold lesions and normal voices [Срок оценки: 90 minutes]
  • Compare mean airflow rate between benign vocal fold lesions and normal voices [Срок оценки: 90 minutes]

Критерии участия

Inclusion Criteria - Healthy Control:

  • Age 4-65 years
  • Normal voice
  • No history of voice or other pertinent health disorders

Exclusion Criteria - Healthy Control:

  • Neuromuscular disorder affecting the larynx
  • History of respiratory or laryngeal disease
  • History of smoking
  • Hearing impairment
  • Cognitive impairment that might impact ability to perform the tasks required by the study

Inclusion Criteria - Abnormal Voice:

  • Age 4-17
  • Laryngeal pathology

Exclusion Criteria - Abnormal Voice:

  • No laryngeal disorder

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Другое

Центры проведения

США · 2 центра
  • University of Iowa — Iowa City
  • University of Wisconsin - Madison — Madison

Идентификаторы

NCT: NCT06975046 · 2024-1776 · A539770 · SMPH/SURGERY/OTOLARYNGOLOGY · Protocol Version 11/20/2024 · 1R01DC021415

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗