Acute Intermittent Hypoxia and Breathing in Neuromuscular Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 4
- 主要终点
- Percent Change in Maximal Inspiratory Pressure (MIP)
研究概览
简要总结
This project seeks to investigate the effects of a single acute intermittent hypoxia (AIH) session on respiratory and non-respiratory motor function and EMG (electromyography) activity on patients with ALS (amyotrophic lateral sclerosis) and healthy controls.
详细描述
Most ALS patients survive less than 5 years after diagnosis, and the main cause of death is respiratory failure. The investigators are interested in the therapeutic potential of acute intermittent hypoxia (AIH) for individuals with neuromuscular diseases, such as ALS. More than two decades of research indicates AIH elicits meaningful respiratory and non-respiratory motor recovery. Acute intermittent hypoxia (AIH) consists of alternating periods of breathing mildly hypoxic (lowered oxygen concentration) and normoxic (normal oxygen concentration) air.
The investigators propose to study mechanisms of respiratory plasticity associated with a single presentation of mild AIH. The fundamental hypothesis guiding this proposal is that even a single AIH trial improves respiratory (and non-respiratory) motor function in ALS patients procedure. Participants will then be asked to breathe air with reduced oxygen for short periods of time, for a duration of 45 minutes. The activity of your muscles and your heart function will be monitored throughout the procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Participants will be blind to the order of the AIH/sham AIH visits, but this information will be provided to the participant after completion of last visit.
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •a healthy adult
- •clinical diagnosis of ALS
- •baseline FVC >60% predicted for age, sex and height.
排除标准
- •diagnosed cardiovascular disease
- •a BMI >35 kg/m2
- •currently take selective serotonin reuptake inhibitors (SSRI)
- •history of seizures
- •history of hospitalization for sepsis
- •respiratory infection or took antibiotic medications within the past 4 weeks
- •use external respiratory support during any waking hours
- •participate in a pharmaceutical trial to treat ALS
- •have any other medical condition the PI or medical director identify would make it unsuitable to participate.
结局指标
主要结局
Percent Change in Maximal Inspiratory Pressure (MIP)
时间窗: 3 Hours
MIP is a maximal voluntary static contraction of the inspiratory muscles against a closed valve, measured at the mouth. The test will be repeated until 3 measurements are obtained within 10% variability and an average of the three trials is reported. The change in MIP will be the percent difference in pressure between the averaged baseline MIP and the averaged follow-up measure, which is tested 60 minutes after the gas intervention.
Percent Change in Maximal Voluntary Grip Force
时间窗: 3 Hours
Maximal static voluntary handgrip contractions will be evaluated in a seated position with the arm at the side and elbow flexed to 90 degrees. The test will be repeated until 3 measurements are obtained within 10% variability and then averaged. The change in grip will be the percent difference in force between the averaged baseline grip and the averaged follow-up grip measure, which is tested 60 minutes after the gas intervention.
Percent Change in Sniff Nasal Inspiratory Pressure
时间窗: 3 Hours
Maximal voluntary contractions of the inspiratory muscles measured with a pressure sensor placed in the nare. The test will be repeated until 3 measurements are obtained within 10% variability and then averaged. The change in sniff nasal inspiratory pressure will be the percent difference in pressure between the averaged baseline sniff nasal inspiratory pressure and the averaged follow-up measure, which is tested 60 minutes after the gas intervention.
次要结局
- Percent Change in Minute Ventilation(3 Hours)
- Occlusion Pressure (P0.1)(3 Hours)
- Percentage Change in Respiratory EMG Vector Magnitude(3 Hours)