Portable Oxygen Concentrator (POC) Versus Standard of Care in Patients With Long-COVID Cognitive Impairment: a Randomized Crossover Exploratory Pilot Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Inogen Inc.
- 入组人数
- 21
- 试验地点
- 4
- 主要终点
- COVID-19 related brain hypoxia and peripheral oxygen saturation
研究概览
简要总结
A prospective, open label, randomized, crossover, pilot, exploratory study to describe the effect of the Inogen One® G4 POC on brain hypoxia, peripheral oxygen saturation and cognitive function in adults with longterm- COVID.
详细描述
After a 2-week screening/baseline evaluation, participants will be randomized in a 1:1 allocation ratio to one of the following 2 sequences: 1) portable oxygen concentrator (POC) for a first 2-week period followed by standard of care (SOC) for a second 2-week period or 2) SOC for a first 2-week period followed by POC for a second 2-week period. There will be a washout period of one week between the two treatment periods. A total of 10 subjects will be enrolled per sequence.
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
- 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
- •Ability and willingness to give written informed consent prior to any study-specific screening procedures and to comply with the requirements of the study
- •Male or female, aged ≥ 18 years of age
- •Diagnosed with Long-COVID
- •Patient self-reported concerns regarding cognitive functioning or recent diagnosis of COVID-19 related cognitive impairment
- •MoCA test scores ranging from 13 to 25/30 at screening
- •Oxygen saturation SpO2 ≤ 93 % on fingertip pulse oximetry and/or < 60% on brain NIRS, at rest or during effort and/ or 10% relative decrease in brain saturation during exercise as compared to baseline value at screening
- •Ability to perform exercise treadmill test at screening
- •Tolerability of pulsed oxygen (O2) therapy delivered by POC at screening
- •Willingness and ability to wear POC.
排除标准
- •Contraindication to the use of POC including allergy to cannula material
- •Pregnancy or planning to become pregnant during the study
- •Non-COVID-related cause for cognitive impairment (such as Parkinson's disease, multiple sclerosis, Alzheimer's disease, stroke, brain tumor, or dementia)
- •Subjects with respiratory infection at screening or randomization and/or acute bronchitis requiring antibiotics at the time of randomization or expected during the treatment
- •Participation in other interventional clinical trial within 30 days of randomization or expect to participate in any other investigational clinical trial during the conduct of this trial
- •Subjects who should be excluded in the opinion of the investigator
结局指标
主要结局
COVID-19 related brain hypoxia and peripheral oxygen saturation
时间窗: 14+/-3 days
To describe the effect of the Inogen One® G4 POC on COVID-19 related brain hypoxia and peripheral oxygen saturation
VO2max during cardiopulmonary exercise test
时间窗: 14+/-3 days
To describe the effect of the Inogen One® G4 POC on VO2max during cardiopulmonary exercise test
MoCA test
时间窗: 14+/-3 days
To describe the effect of the Inogen One® G4 POC on Cognitive performance using the MoCA test
Other neuropsychological tests
时间窗: 14+/-3 days
To describe the effect of the Inogen One® G4 POC on Cognitive health assessments using other neuropsychological tests
次要结局
- Pulmonary function(14+/-3 days)
- Anxiety, mood, and subjective cognitive impairment(14+/-3 days)
- Functional status(14+/-3 days)
- Safety outcomes(14+/-3 days)