Influence of Intermittent Hypoxia on Loop Gain in Healthy Subjects
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- To evaluate the effect of intermittent hypoxia for 6 hours on the evolution of Loop Gain
研究概览
简要总结
Sleep apnoea-hypopnoea syndrome (SAHOS), which causes numerous comorbidities, particularly cardiovascular ones, is widespread worldwide today and incurs significant healthcare costs.
Current research in this field focuses on identifying different phenotypes in affected patients in order to provide more personalised treatment.
One of these phenotypes appears to be linked to instability in ventilatory control due to an increase in loop gain (LG) in these subjects.
However, the pathophysiology of this ventilatory control instability due to increased LG is not fully understood. It is still difficult to determine whether subjects have an intrinsically high LG or if exposure to intermittent hypoxia during OSA promotes an increase in LG.
It has also been demonstrated that OSA causes vascular hyperreactivity by increasing oxidative stress through elevated ROS production. This leads to endothelial dysfunction in response to intermittent hypoxia associated with apnoea. Extracellular vesicles (microvesicles and exosomes) have been shown to play a role in this endothelial response. These extracellular vesicles are essential for intercellular communication in both physiological and pathological situations, such as SAHOS.
Therefore, the objective of this research is to determine whether exposure to intermittent hypoxia and changes in microvesicle phenotype could influence LG, which could lead to new therapeutic advances in the context of SAHOS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects aged 18 to 45
- •BMI between [18-25] kg/m2
- •No known sleep disorders
- •Free subjects, not under guardianship or curatorship or subordination
- •Persons affiliated with or beneficiaries of a Social Security scheme
- •Signature of informed consent after clear and honest information about the study
排除标准
- •Active smoking or cessation within the last 3 months and total consumption > 10 pack-years
- •Alcohol or drug addiction
- •Excessive coffee consumption (> 3 espressos/day)
- •History of acute mountain sickness (presence of symptoms such as dizziness, headaches, nausea/vomiting, and incapacitating fatigue during or after a stay at high altitude)
- •Living at high altitude (above 3,000 meters, continuously for more than 6 months during the last 10 years)
- •History of respiratory and/or cardiovascular and/or renal and/or neurological disease (migraines, epilepsy)
- •Anemia, sickle cell anemia
- •Any medication associated with oxygen metabolism and any psychotropic medication (anxiolytics, sedatives, antidepressants, neuroleptics, muscle relaxants, etc.) that may interfere with motor and respiratory control, muscle strength, or sleep quality
- •Women of childbearing age who do not use effective contraception (hormonal/mechanical: oral, injectable, transcutaneous, implantable, intrauterine device, or surgical: tubal ligation, hysterectomy, total ovariectomy)
- •Concurrent participation in another clinical research study affecting respiratory control or respiratory muscles
- •Persons benefiting from enhanced protection, namely minors, persons deprived of their liberty by judicial or administrative decision, persons staying in a healthcare facility
研究组 & 干预措施
Arm A : ambient air then intermittent hypoxia
T1 : Conduct the experiment in ambient air (without hypoxia) for six hours. T2 : Then, after a washout period of at least seven days, conduct the experiment in intermittent hypoxia via the hypoxia chamber for six hours.
干预措施: Normoxia (Procedure)
Arm A : ambient air then intermittent hypoxia
T1 : Conduct the experiment in ambient air (without hypoxia) for six hours. T2 : Then, after a washout period of at least seven days, conduct the experiment in intermittent hypoxia via the hypoxia chamber for six hours.
干预措施: Intermittent hypoxia (Procedure)
Arm B : intermittent hypoxia then ambient air
T1 : Conduct an experiment involving intermittent hypoxia in the hypoxia chamber for six hours.
T2 : Then, after a washout period of at least seven days, conduct an experiment involving ambient air (without hypoxia).
干预措施: Intermittent hypoxia (Procedure)
Arm B : intermittent hypoxia then ambient air
T1 : Conduct an experiment involving intermittent hypoxia in the hypoxia chamber for six hours.
T2 : Then, after a washout period of at least seven days, conduct an experiment involving ambient air (without hypoxia).
干预措施: Normoxia (Procedure)
结局指标
主要结局
To evaluate the effect of intermittent hypoxia for 6 hours on the evolution of Loop Gain
时间窗: through study completion (visit 1 and visit 2), an average of 14 months
Loop gain is the product of 'controller gain' (ventilatory responsiveness to CO₂ above eupnoea) and 'plant gain' (the ventilatory increase required for a given reduction in PaCO₂). Loop gain will be measured before (30 minutes of rest following the participant's arrival) and after (20 minutes before the end of the hypoxia chamber session) the test or control condition (intermittent hypoxia or ambient air). The following ventilatory parameters will be measured using a gas exchange measuring device to calculate loop gain, plant gain and controller gain: * PETCO₂ in mmHg * PETO₂ in mmHg * Minute ventilation (VE), measured in mL/min (tidal volume x respiratory rate). The focus will be on the average loop gain value measured over spontaneous breathing cycles of five to ten minutes. The evaluation criterion will be the difference in the average loop gain value before and after the experimental conditioning (i.e. observation of the change).
次要结局
- To compare the evolution of controller gain and plant gain between experimental conditions in hypoxia and ambient air(through study completion (visit 1 and visit 2), an average of 14 months)
- To compare the change in the quantity of extracellular vesicles between experimental conditions in hypoxia and ambient air.(through study completion (visit 1 and visit 2), an average of 14 months)
- To assess whether changes in the quantity of extracellular vesicles (and microvesicles) correlate with changes in loop gain, both under experimental conditions in hypoxia and under experimental conditions in ambient air.(through study completion (visit 1 and visit 2), an average of 14 months)
- To compare changes in loop gain between experimental conditions in hypoxia and ambient air, on the one hand in the subgroup of patients with hyperventilation syndrome and on the other hand in the subgroup of patients without hyperventilation syndrome.(through study completion (visit 1 and visit 2), an average of 14 months)