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Набор скоро начнётся NCT07470086

The Role of Environmental Temperatures 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: Thermoneutral temperature environment, Cold temperature environment, Hot temperature environment.
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 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 study is to determine whether exposing individuals to thermal stress alters breathing perception and cognitive performance during inspiratory resistance. Participants will perform inspiratory resistance breathing under thermoneutral, heat, and cold conditions to determine whether thermal stress amplifies WOB, breathing perception, and cognitive impairment.

Подробное описание

Warfighters often face thermal stressors that increase the WOB, even with life-support systems in place. Both cold and heat stress elevate the WOB independently, without requiring increased inspiratory resistance. Cold stress stimulates ventilation and causes a biphasic bronchiolar response: inhaling cold air during hyperventilation leads to initial bronchodilation followed by bronchoconstriction, tightening the bronchioles and increasing airflow resistance, and thus the WOB. Warfighters are also exposed to extreme heat and hyperthermia-induced hyperventilation occurs when core body temperature reaches around 38.0°C, significantly correlating with increased WOB during heat stress. Warfighters frequently experience these environmental stressors alongside elevated breathing resistance, especially during underwater diving missions in varying temperatures or in high-performance aircraft with OBOGs exposed to extreme heat.

A critical gap in knowledge exists regarding whether high inspiratory resistance combined with thermal stress amplifies the WOB, altering the perception of breathing and cognitive and physiological responses. The study will investigate the WOB, breathing perception, cognitive function, and physiological responses under combined inspiratory resistance and thermal stress (thermoneutral, heat, and cold). It's hypothesized that WOB will increase during heat and cold stress, resulting in greater perceptions of breathing difficulty and decreased cognitive performance compared to thermoneutral conditions.

Participants will complete 4 study visits: a screening/familiarization visit (Study Day 0) followed by three experimental visits (Study Day 1, Day 2, and Day 3). 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 every10 minutes. After the breathing task, participants will complete lung and respiratory muscle function tests.

Prior to the experimental visits, participants will be randomized to the order in which they are exposed to the interventional conditions (hot, cold, or thermoneutral). Upon arrival, an esophageal balloon will be placed to measure the pressure around the heart and lungs. Participants will then be placed into an environmental chamber (to control humidity) while wearing a special suit which allows different temperatures of water to be circulated through tubes which will expose them to the temperature conditions for roughly 30 minutes before starting the full-length breathing tasks. During thermoneutral conditions 34°C water will be perfused through special suit while participants resting the chamber set to 24°C and 40% room humidity. During the cold condition, 4°C water will be perfused through the special suit while participants rest in the chamber set to 4°C and 10% room humidity. The breathing task will commence when esophageal temperature reaches -1°C and -2°C relative to baseline esophageal temperature. During the hot condition, 50°C water will be perfused through the special suit while participants rest in the chamber set to 40°C and 40% room humidity. The breathing task will commence when esophageal temperature reaches +1°C and +2°C relative to baseline esophageal temperature. At each experimental visit, participants will complete a full-length breathing task, in which they inspire against a predetermined resistive load for 60 minutes. Biometric monitoring will be continuously performed, and cognitive assessments and participant ratings during the breathing tasks will be performed at 45- and 90-minutes of the condition exposure. A 7 day washout period will be observed between the experimental visits.

Вмешательства

  • Другое Thermoneutral temperature environment
    During thermoneutral conditions 34°C water will be perfused through special suit while participants resting the chamber set to 24°C and 40% room humidity.
  • Другое Cold temperature environment
    During the cold condition, 4°C water will be perfused through the special suit while participants rest in the chamber set to 4°C and 10% room humidity.
  • Другое Hot temperature environment
    During the hot condition, 50°C water will be perfused through the special suit while participants rest in the chamber set to 40°C and 40% room humidity.

Первичные конечные точки

  • Change in Stroop Color-Word Test Time Performance [Срок оценки: Before and after each breathing task on Days 1, 2, 3 (each approximately 90 minutes in duration)]
  • Change in Stroop Color-Word Test Error Performance [Срок оценки: Before and after each breathing task on Days 1, 2, 3 (each approximately 90 minutes in duration)]
  • Change in Perception of Dyspnea Intensity [Срок оценки: Before and after each breathing task on Days 1, 2, 3 (each approximately 90 minutes in duration)]
  • Change in Perception of Dyspnea Unpleasantness [Срок оценки: Before and after each breathing task on Days 1, 2, 3 (each approximately 90 minutes in duration)]
Вторичные конечные точки (8)
  • Change in Diaphragm Thickness [Срок оценки: Before and after each breathing task on Days 1, 2, 3 (each approximately 90 minutes in duration)]
  • Change in Heart Rate Variability [Срок оценки: Before and after each breathing task on Days 1, 2, 3 (each approximately 90 minutes in duration)]
  • Change in Peripheral Oxygen Saturation [Срок оценки: Before and after each breathing task on Days 1, 2, 3 (each approximately 90 minutes in duration)]
  • Change in Blood Pressure - Brachial Artery [Срок оценки: Before and after each breathing task on Days 1, 2, 3 (each approximately 90 minutes in duration)]
  • Change in Blood Pressure - Finger Photoplethysmography [Срок оценки: Before and after each breathing task on Days 1, 2, 3 (each approximately 90 minutes in duration)]
  • Change in Heart Rate [Срок оценки: Before and after each breathing task on Days 1, 2, 3 (each approximately 90 minutes in duration)]
  • Change in Cerebral Blood Oxygen Kinetics [Срок оценки: Before and after each breathing task on Days 1, 2, 3 (each approximately 90 minutes in duration)]
  • Change in Cerebral Blood Velocity [Срок оценки: Before and after each breathing task on Days 1, 2, 3 (each approximately 90 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: NCT07470086 · 28381 - Aim 3 · FOAAFRLAFOSR20240007

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗