Respiratory and Real-time Dynamics in Exercise-Induced Paradoxical Vocal Fold Motion

Обзор

The overall objectives of the proposed research are to: 1. Evaluate the diagnostic validity of a novel mechano-acoustic signatures of task-characteristic activity during symptomatic and asymptomatic breathing in Exercise-Induced Laryngeal Obstruction (EILO) patients with the use of a novel miniature, soft wearable skin-mounted device, 2. Identify the mechanism/s of paradoxical respiratory control in EILO by quantifying the relationship between pulmonary mechanics, partial pressure of carbon dioxide (PCO2) maintenance, and vocal fold aperture prior to and during symptomatic and asymptomatic exercise ventilation, and 3. Identify unique biophysiological factors contributing to EILO among exercisers with and without EILO. Findings will be highly novel and clinically significant for early identification and management of EILO. For the study there are three separate visits: 1. Free running with the device on the neck 2. Exercise treadmill study 3. Undergoing MRI (Magnetic Resonance Imaging) of the vocal tract.

Вмешательства

• Препарат Carbon Dioxide
  Breathing Hypercapnic Gas (10% CO2 (carbon dioxide) and 21%O2 (oxygen), balance N210% (nitrogen))
• Поведенческое Breathing treatment
  Random Assignment to breathing conditions (rest breathing, rapid breathing, quick nasal sniff, pursed lip breathing), in a single blinded randomized design

Первичные конечные точки

• Device measurements from real time running [Срок оценки: Baseline and Periprocedural]
• Device measurements from real time running [Срок оценки: Baseline and Periprocedural]
• Device measurements from real time running [Срок оценки: Baseline and Perioprocedural]
• Treadmill testing [Срок оценки: Baseline and Perioprocedural]
• Treadmill testing [Срок оценки: Base-line]
• Treadmill testing [Срок оценки: Breath-by-breath baseline and Perioprocedural]
• Treadmill testing [Срок оценки: Baseline and Periprocedural]
• MRI Upper Airway Size [Срок оценки: Baseline]
• Upper Airway Aerodynamics [Срок оценки: Baseline and Periprocedural]
• Upper Airway Aerodynamics [Срок оценки: Baseline and Periprocedural]

Вторичные конечные точки (1)

• Self-rating of dyspnea [Срок оценки: Baseline]

Критерии участия

Inclusion Criteria for Exercise-Induced Laryngeal Obstruction (EILO):

• Physically active >2.5 hours per week
• Patients with EILO, as diagnosed by routine clinical examination by physician and/or speech language pathologist
• Age range of 18-26 years
• Greater difficulty breathing inside compared to out and difficulty breathing which is exacerbated at peak exercise and stops 1-5 minutes after exercise
• Score of 7 or higher on the Dyspnea Index, which is a validated instrument to capture participant self-report of upper airway dyspnea symptoms.
• Classified as low risk, based on the modified Physical Activity Readiness Questionnaire (PAR-Q) questionnaire, body mass index, and non-smoking status
• Negative history of voice disorders, self-report of cognitive difficulties, asthma or other lung disease, cardiac disease, serious orthopedic injuries, current uncontrolled hypertension, illicit drug use, seizure/epilepsy, claustrophobia, use of beta blockers.
• No metallic, mechanical or magnetic implants such as cardiac devices, cochlear, or other non-removable ear implants, any prosthesis, stents, deep brain stimulator, etc.

Inclusion Criteria for Controls

• Physically active >2.5 hours per week
• Age range of 18-26 years
• Classified as low risk, based on the modified PAR-Q questionnaire, body mass index, and non-smoking status
• Negative history of voice disorders, self-report of cognitive difficulties, asthma or other lung disease, cardiac disease, serious orthopedic injuries, current uncontrolled hypertension, illicit drug use, seizure/epilepsy, claustrophobia, use of beta blockers.
• No metallic, mechanical or magnetic implants such as cardiac devices, cochlear, or other non-removable ear implants, any prosthesis, stents, deep brain stimulator, etc.

Exclusion Criteria for EILO:

• Individuals older than 26 years and younger than 18 years of age.
• Women who are pregnant or could possibly be pregnant.
• BMI > 25 kg/m2
• A 'yes' answer to any of the 14 questions on the PAR-Q pre-participation questionnaire
• Current smoker
• Positive history of voice disorders, self-report of cognitive difficulties, asthma or other lung disease, cardiac disease, serious orthopedic injuries, current uncontrolled hypertension, illicit drug use, seizure/epilepsy, claustrophobia, use of beta blockers.
• Presence of metallic, mechanical or magnetic implants such as cardiac devices, cochlear, or other non-removable ear implants, any prosthesis, stents, deep brain stimulator, etc.
• Do not report the following: Greater difficulty breathing inside compared to out and difficulty breathing which is exacerbated at peak exercise and stops 1-5 minutes after exercise

Exclusion Criteria for Controls

• Individuals older than 26 years and younger than 18 years of age.
• Women who are pregnant or could possibly be pregnant.
• BMI > 25 kg/m2
• A 'yes' answer to any of the 14 questions on the PAR-Q pre-participation questionnaire
• Current smoker
• Positive history of voice disorders, self-report of cognitive difficulties, asthma or other lung disease, cardiac disease, serious orthopedic injuries, current uncontrolled hypertension, illicit drug use, seizure/epilepsy, claustrophobia, use of beta blockers.
• Presence of metallic, mechanical or magnetic implants such as cardiac devices, cochlear, or other non-removable ear implants, any prosthesis, stents, deep brain stimulator, etc.
• Significant acute or chronic medical, neurologic, or illness in the patient that, in the judgment of the Principal Investigator, could compromise subject safety, limit the ability to complete the study, and/or compromise the objectives of the study

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

Простое слепое

Основная цель

Другое

Центры проведения

США · 1 центр

• Indiana University — Bloomington

Идентификаторы

NCT: NCT07420530 · 29009 · R01DC023381

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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