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临床试验/NCT06714435
NCT06714435
已完成
不适用

Effect of Intermittent Hypoxia on Ventilatory Endurance in Healthy Volunteers

Poitiers University Hospital1 个研究点 分布在 1 个国家目标入组 28 人2025年1月16日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Intermittent Hypoxia
发起方
Poitiers University Hospital
入组人数
28
试验地点
1
主要终点
To compare the inspiratory endurance of healthy volunteers after 6h of continuous breathing in room air and after 6h of continuous exposure to intermittent hypoxia in a hypoxic chamber.
状态
已完成
最后更新
5个月前

概览

简要总结

Sleep apnoea syndrome is a common disorder responsible for poor sleep quality and repeated oxygen depletion in the blood. Patients suffering from this disease experience a reduction in their endurance, i.e. their ability to make prolonged efforts. This loss of muscular endurance affects breathing in particular. It is known that poor sleep reduces endurance, but it is not knwon whether the repeated lack of oxygen for several hours at night also has this effect. This information could help improve the management of certain acute respiratory illnesses (asthma attacks, respiratory infections, etc.).

This project therefore seeks to establish a link between repeated oxygen deprivation and a reduction in the human brain's ability to train respiratory muscles. To this end, the healthy volunteers in this study will perform the same breathing exercise (breathing for as long as possible through a mask that makes inspiration difficult) twice: once after 6 hours' exposure to repeated oxygen deprivation, and once under conditions of normal oxygenation. The order of these exercises will be randomized. These exercises will take place in a special room, a hypoxia chamber, where it is possible to deplete the air breathed in oxygen.

注册库
clinicaltrials.gov
开始日期
2025年1月16日
结束日期
2025年10月14日
最后更新
5个月前
研究类型
Interventional
研究设计
Crossover
性别
All

研究者

责任方
Sponsor

入排标准

入选标准

  • Non-excessive coffee drinker (\< 3 espressos / day)
  • Non-smoker or weaned for 3 months and total consumption \< 10 packs/year
  • With a BMI within \]18 - 25\[ kg/m².
  • Benefiting from a Social Security plan or benefiting from one through a third party
  • Giving free, informed and signed consent, after receiving clear and fair information about the study.
  • Non-inclusion Criteria:
  • History of respiratory or ENT disease (asthma, chronic bronchitis, COPD, respiratory allergy, swallowing disorders, oropharyngeal malformation, obstructive or central sleep apnea-hypopnea syndrome, alveolar hypoventilation syndrome)
  • Respiratory, cardiovascular, muscular, neurological or diabetic pathology or disorders
  • Raynaud's disease/syndrome
  • History of epilepsy or history of malaise suggestive of epilepsy

排除标准

  • 未提供

结局指标

主要结局

To compare the inspiratory endurance of healthy volunteers after 6h of continuous breathing in room air and after 6h of continuous exposure to intermittent hypoxia in a hypoxic chamber.

时间窗: through study completion, an average of 2 years

次要结局

  • After 6 h of continuous breathing in room air and after 6 h of continuous exposure to intermittent hypoxia in a hypoxic chamber, compare Maximum Inspiratory Pressure (PImax) before and after the inspiratory endurance test.(through study completion, an average of 2 years)
  • Compare inspiratory cortical control measured by EEG over the first 15 and last 15 minutes of the inspiratory endurance test after 6 h of continuous breathing in room air and after 6 h of continuous exposure to intermittent hypoxia in a hypoxic chamber.(through study completion, an average of 2 years)
  • Compare respiratory discomfort with a visual analog scale at the start of the endurance test after 6 h of continuous breathing in room air and after 6 h of continuous exposure to intermittent hypoxia in a hypoxic chamber.(through study completion, an average of 2 years)
  • Compare the time to onset of respiratory discomfort in the inspiratory endurance test with a visual analog scale after 6 h of continuous breathing in room air and after 6 h of continuous exposure to intermittent hypoxia in a hypoxic chamber.(through study completion, an average of 2 years)
  • Compare sensory perception of inspiratory effort after 6 h of continuous breathing in room air and after 6 h of continuous exposure to intermittent hypoxia in a hypoxic chamber.(through study completion, an average of 2 years)
  • Compare the quantity and phenotype of circulating microvesicles in ambient air or in intermittent hypoxia.(through study completion, an average of 2 years)
  • Compare systolic pulmonary artery pressure in room air or intermittent hypoxia using trans-thoracic echography.(through study completion, an average of 2 years)
  • Compare echographic signs of right ventricular function in room air or intermittent hypoxia using trans-thoracic echography.(through study completion, an average of 2 years)

研究点 (1)

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