Effect of Intermittent Hypoxia on Ventilatory Endurance in Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 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.
研究概览
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 25 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
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
- •Psychiatric history requiring hospitalization
- •Liver failure
- •Renal insufficiency
- •History of acute mountain sickness (presence during or after a stay at altitude of symptoms of vertigo, headache, nausea/vomiting and incapacitating fatigue: Lake Louise score > 0)
- •History of migraines
- •Taking medications that interfere with respiratory function or cardiovascular function, or psychotropic drugs ( anxiolytic, sedative, antidepressant, neuroleptic, muscle relaxant, etc.).
- •Alcohol or drug dependence
- •Anemia, sickle-cell anemia
- •SpO2 < 97% at rest in room air
- •Currently participating in another clinical study
- •Protected persons within the meaning of article L1121-5 to 8 (persons benefiting from enhanced protection, i.e. minors, persons deprived of their liberty by a judicial or administrative decision, pregnant or breast-feeding women, persons staying in a health or social establishment, adults under legal protection, and patients in emergency situations). - Women with childbearing capacity who do not have effective contraception (hormonal/mechanical: oral, injectable, transcutaneous, implantable, intrauterine device, or surgical: tubal ligation, hysterectomy, total oophorectomy).
- •Incidental finding of acute mountain sickness (Lake Louise score >0)
- •Pregnant woman (incidental finding)
- •Persistence of average sleep time < 6h
- •Non-reversible deterioration in volunteer's state of health within study period
- •Electroencephalogram signal unusable
排除标准
- 未提供
研究组 & 干预措施
Groupe 1
Control visit in normoxia at V1 and then test visit in intermittent hypoxia at V2
干预措施: Intermittent hypoxia (Other)
Groupe 1
Control visit in normoxia at V1 and then test visit in intermittent hypoxia at V2
干预措施: Normoxia (Other)
Groupe 2
Test visit in intermittent hypoxia at V1 and then control visit in normoxia at V2
干预措施: Intermittent hypoxia (Other)
Groupe 2
Test visit in intermittent hypoxia at V1 and then control visit in normoxia at V2
干预措施: Normoxia (Other)
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)