Intermittent Low Oxygen Breathing: A First Study Testing Different Disease Stages in People Living With Multiple Sclerosis
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 9
研究概览
简要总结
This study will look at the safety, tolerability and feasibility of a non-invasive treatment called Acute Intermittent Hypoxia (AIH) in people with Multiple Sclerosis (MS) at different stages of the disease course.
详细描述
AIH is a treatment where people breathe reduced amounts of oxygen (10% oxygen) for a short period of time alternating with normal oxygen levels (21%) through a facemask that is attached to an oxygen tank with 10% 02. Participants will undergo 6 AIH treatment sessions over 3-4 weeks.
AIH will be administered to 3 unique groups of people: 1) People with advanced MS disability who are no longer ambulatory, 2) People who experienced a disabling relapse within the past 4 weeks and 3) People with non-active, progressive MS who retain some ambulatory ability.
There will be one baseline and two post-treatment assessments (1 and 5 weeks following the last AIH session).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •People with a confirmed diagnosis of MS and advanced disability level (Expanded Disability Status Scale (EDSS) >6.5 and <9)
- •Without relapse for at least 90 days prior
- •Older than age 18
- •People with a confirmed diagnosis of relapsing remitting MS
- •Acute disabling relapse onset within the past 4 weeks. A disabling relapse will be defined as at least 1.0-point increase on the EDSS.
- •Older than age 18
- •People with a confirmed diagnosis of MS that is non-active and progressive (Primary or Secondary Progressive MS). Non-active will be defined as without MS relapse, new/enlarging or enhancing MRI lesions within the past 1 year.
- •EDSS <=6.5
- •Older than age 18
排除标准
- •Pregnancy
- •Any of the following documented respiratory disorders: obstructive sleep apnea, chronic obstructive pulmonary disease, uncontrolled asthma, hypoxic pulmonary disease, respiratory infection in the previous 3 months
- •Ischemic cardiac disease
- •Cardiac arrhythmia
- •Severe hypertension (>160/100)
- •Seizure disorders
- •Medically unstable in another capacity
- •Unable to provide informed consent
研究者
Katherine Knox
Principal Investigator
University of Saskatchewan