Меню
Набор скоро начнётся NCT07470099

The Role of Breathing Perception in Respiratory Control

Без фазы С лечением Work of Breathing

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: Ambient Noise, Increased Auditory Feedback, Noise Distraction.
Кому может быть актуально
Состояния в реестре: Work of Breathing. Базовые параметры: 18 лет — 40 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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Optimizing Mind-Body Interactions in Respiratory Control During Operationally Relevant Environmental Stressors

Обзор

Warfighters are frequently exposed to environments and life-support systems that increase breathing resistance and the work of breathing (WOB), such as aircraft on-board oxygen generation systems and underwater breathing apparatuses. Elevated WOB then increases the perception of breathing difficulty (dyspnea) and has been associated with impaired cognitive performance, including slower reaction time and reduced accuracy during attention-demanding tasks. These effects are particularly concerning in operational settings that require rapid decision-making and precise motor responses. Despite growing recognition of this issue, critical gaps remain regarding strategies to mitigate the perceptual and cognitive consequences of elevated inspiratory resistance, especially under realistic operational stressors. The objective of this experiment is to determine whether modifying the sensory perception of breathing alters breathing perception and cognitive performance during inspiratory resistance. Auditory feedback of ventilation will be manipulated (normal, reduced, or amplified) to assess whether altering breathing-related sensory input affects breathing perception and cognitive performance without changing mechanical load.

Подробное описание

In some instances, reducing inspiratory resistive loads (e.g., OBOGs, SCUBA) for Warfighters may not be feasible, but understanding how breathing perception is affected by resistance is essential. Auditory feedback of ventilation significantly influences breathing awareness, and as the WOB increases, this perception intensifies due to enhanced auditory input. This heightened awareness can distract and tax cognitive processing. Recent studies indicate that auditory distractions, like music during exercise, can lessen dyspnea and respiratory and whole-body discomfort in healthy individuals and those with chronic obstructive pulmonary disease. This effect may stem from reduced auditory feedback or improved emotional states linked to music. However, a key knowledge gap exists: it is unclear whether reducing auditory feedback of ventilation during increased inspiratory resistance affects breathing perception and cognitive function. The study will assess the impact of different auditory feedback of ventilation conditions (normal, eliminated via noise distraction, and amplified) on cognitive function under high inspiratory resistance. It's hypothesized that reducing auditory feedback of ventilation will not alter the WOB but will decrease breathing perception and enhance cognitive performance compared to standard or amplified feedback.

Participants will complete two study visits: a screening/familiarization visit (Study Day 0) followed by one experimental visit (Study Day 1). Participants will be instructed to avoid caffeine, alcohol, stimulant medication, pain/anti-inflammatory medication, cannabis and cannabis related products, and vigorous exercise for at least 24 hours prior to experimental visits. On Study Day 0, participants will complete a short familiarization breathing task in which they will breathe for 10 minutes through an 8-10mm hole at the end of a customized device, generating a pre-determined inspiratory resistance of 6-9.5 centimeters of water per liter per second (cmH2O/L/s). During the breathing task, cerebral vascular, cardiovascular and autonomic activity responses will be measured. Every 5 minutes during the breathing test, participants will be asked to rate breathing intensity and unpleasantness, and perform an inspiratory capacity maneuver. Cognitive assessments will be administered every 10 minutes. After the breathing task, participants will complete lung and respiratory muscle function tests.

Prior to Study Day 1 (the experimental visit), participants will be randomized to the order in which they are exposed to the interventional conditions (ambient/normal auditory feedback, enhanced auditory feedback, or removed auditory feedback with replacement of a self-selected music playlist). Upon arrival, an esophageal balloon will be placed to measure the pressure around the heart and lungs. Participants will then complete three full-length breathing tasks, in which they inspire against a predetermined resistive load for 60 minutes, with auditory conditions in the order of randomization. Biometric monitoring, cognitive tasks and participant ratings during the breathing tasks will be completed with the same frequency as Study Day 0. A 1-hour rest period will be observed between the breathing tasks.

Вмешательства

  • Другое Ambient Noise
    Participants will complete the breathing task with ambient (or normal) auditory feedback (\~10 decibels).
  • Другое Increased Auditory Feedback
    Participants will complete the breathing task with increased auditory feedback of ventilation (\~70 decibels). Specifically, a small microphone will be placed in the device that participants breathe through to increase the sound of the participants breath.
  • Другое Noise Distraction
    Participants will complete the breathing task without auditory feedback of ventilation. Specifically, participants will wear noise cancelling headphones and will listen to a self-selected music playlist at a constant volume (\~80 decibels).

Первичные конечные точки

  • Change in Stroop Color-Word Test Time Performance [Срок оценки: Before and after each Day 1 breathing task (approximately 60 minutes in duration)]
  • Change in Stroop Color-Word Test Error Performance [Срок оценки: Before and after each Day 1 breathing task (approximately 60 minutes in duration)]
  • Change in Perception of Dyspnea Intensity [Срок оценки: Before and after each Day 1 breathing task (approximately 60 minutes in duration)]
  • Change in Perception of Dyspnea Unpleasantness [Срок оценки: Before and after each Day 1 breathing task (approximately 60 minutes in duration)]
Вторичные конечные точки (8)
  • Change in Diaphragm Thickness [Срок оценки: Before and after each Day 1 breathing task (approximately 60 minutes in duration)]
  • Change in Heart Rate Variability [Срок оценки: Before and after each Day 1 breathing task (approximately 60 minutes in duration)]
  • Change in Peripheral Oxygen Saturation [Срок оценки: Before and after each Day 1 breathing task (approximately 60 minutes in duration)]
  • Change in Blood Pressure - Brachial Artery [Срок оценки: Before and after each Day 1 breathing task (approximately 60 minutes in duration)]
  • Change in Blood Pressure - Finger Photoplethysmography [Срок оценки: Before and after each Day 1 breathing task (approximately 60 minutes in duration)]
  • Change in Heart Rate [Срок оценки: Before and after each Day 1 breathing task (approximately 60 minutes in duration)]
  • Change in Cerebral Blood Oxygen Kinetics [Срок оценки: Before and after each Day 1 breathing task (approximately 60 minutes in duration)]
  • Change in Cerebral Blood Velocity [Срок оценки: Before and after each Day 1 breathing task (approximately 60 minutes in duration)]

Критерии участия

Критерии включения

  • Between the ages of 18-40 years old.
  • English speaking and reading.
  • Self-reported weekly activity of at least 120 minutes/week of high intensity exercise for the previous 2 years.
  • Normal pulmonary function assessed by a resting forced expiratory volume in 1 second over forced vital capacity (FEV1/FVC) > 75% of predicted.
  • Normal cognitive function assessed using the Montreal cognitive function test \[18\].
  • Body mass index (BMI) ≤ 35 kg/m2.
  • Females with a regular menstrual cycle that ranges from 21-35 days (eumenorrhea)

Критерии исключения

  • History of smoking or recreational smoking, cardiovascular disease, renal disease, pulmonary disease (including asthma or exercise-induced asthma), neurological disease, and metabolic disease.
  • Are pregnant or could possibly be pregnant by self-report.
  • Are color blind.
  • Known allergy or hypersensitivity latex.
  • Take selective serotonin reuptake inhibitors, stimulant medication, antibiotics, and chronically consume pain medication (Aleve, Tylenol, etc.).
  • Resting blood pressure of > 130mmHg systolic or 90 mmHg diastolic and/or resting pulse rate of > 100 bpm.
  • Females with irregular menstrual cycles (oligomenorrhea) that ranges from 36-90 days, and females with the absence of a menstrual cycle (amenorrhea).
  • Taking birth control for the sole purpose of period cessation (eg., Mirena IUD)

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Открытое
Основная цель
Фундаментальное исследование

Центры проведения

США · 1 центр
  • Multidisciplinary Engineering and Sciences Hall (MESH) — Bloomington

Идентификаторы

NCT: NCT07470099 · 28381- Aim 2 · FOAAFRLAFOSR20240007

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗