Pilot Study to Investigate Possible Non-invasive Treatment for Long COVID (Post COVID-19 Condition) Brain Fog
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Change in cerebral blood flow
研究概览
简要总结
This study aims to assess the effects of both acute and chronic exposures to hypoxia and hypercapnia in patients with Long COVID syndrome.
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
- •English speaking
- •Diagnosis of Long COVID
排除标准
- •Any history of:
- •Coronary artery dissection or aortic dissection
- •Neurological disease (e.g. dementia, Alzheimer's disease, or other brain-related disease)
- •Cerebrovascular disease or stroke
- •If currently has:
- •Moderate-severe chronic obstructive pulmonary disease
- •Uncontrolled moderate-severe asthma
- •Moderate-severe bronchiectasis
- •Moderate-severe interstitial lung disease, requiring the use of supplemental oxygen
- •A necessity to use supplemental oxygen, for any reason
- •New or worsening symptoms (decompensation) of heart failure
- •Right heart disease due to chronic pulmonary disease/sleep apnea
- •Uncontrolled myocardial ischemia or angina
- •Uncontrolled heart arrhythmias
- •Heart or lung infection (e.g. myocarditis or pericarditis)
- •Left main coronary artery stenosis
- •Moderate-severe aortic stenosis
- •Pulmonary embolism, pulmonary infarction, or other blood clots
- •Severe respiratory disease
- •Chronic kidney disease
- •Chronic liver disease
- •Females of childbearing potential will complete a urine pregnancy test at their baseline visit to rule out pregnancy
- •Study staff unable to obtain adequate signal for cerebral blood flow
研究组 & 干预措施
Acute exposure: Placebo, Progressive Carbon Dioxide, Intermittent Hypoxia
Study group will receive the three interventions in this order: Placebo, Progressive Carbon Dioxide, then Intermittent Hypoxia
干预措施: Acute Placebo Visit (Other)
Acute exposure: Placebo, Progressive Carbon Dioxide, Intermittent Hypoxia
Study group will receive the three interventions in this order: Placebo, Progressive Carbon Dioxide, then Intermittent Hypoxia
干预措施: Acute Progressive Carbon Dioxide (Other)
Acute exposure: Placebo, Progressive Carbon Dioxide, Intermittent Hypoxia
Study group will receive the three interventions in this order: Placebo, Progressive Carbon Dioxide, then Intermittent Hypoxia
干预措施: Acute Intermittent Hypoxia (Other)
Acute exposure: Placebo, Intermittent Hypoxia, Progressive Carbon Dioxide
Study group will receive the three interventions in this order: Placebo, Intermittent Hypoxia, Progressive Carbon Dioxide
干预措施: Acute Placebo Visit (Other)
Acute exposure: Placebo, Intermittent Hypoxia, Progressive Carbon Dioxide
Study group will receive the three interventions in this order: Placebo, Intermittent Hypoxia, Progressive Carbon Dioxide
干预措施: Acute Progressive Carbon Dioxide (Other)
Acute exposure: Placebo, Intermittent Hypoxia, Progressive Carbon Dioxide
Study group will receive the three interventions in this order: Placebo, Intermittent Hypoxia, Progressive Carbon Dioxide
干预措施: Acute Intermittent Hypoxia (Other)
Acute exposure: Intermittent Hypoxia, Placebo, Progressive Carbon Dioxide
Study group will receive the three interventions in this order: Intermittent Hypoxia, Placebo, Progressive Carbon Dioxide
干预措施: Acute Placebo Visit (Other)
Acute exposure: Intermittent Hypoxia, Placebo, Progressive Carbon Dioxide
Study group will receive the three interventions in this order: Intermittent Hypoxia, Placebo, Progressive Carbon Dioxide
干预措施: Acute Progressive Carbon Dioxide (Other)
Acute exposure: Intermittent Hypoxia, Placebo, Progressive Carbon Dioxide
Study group will receive the three interventions in this order: Intermittent Hypoxia, Placebo, Progressive Carbon Dioxide
干预措施: Acute Intermittent Hypoxia (Other)
Acute exposure: Intermittent Hypoxia, Progressive Carbon Dioxide, Placebo
Study group will receive the three interventions in this order: Intermittent Hypoxia, Progressive Carbon Dioxide, Placebo
干预措施: Acute Placebo Visit (Other)
Acute exposure: Intermittent Hypoxia, Progressive Carbon Dioxide, Placebo
Study group will receive the three interventions in this order: Intermittent Hypoxia, Progressive Carbon Dioxide, Placebo
干预措施: Acute Progressive Carbon Dioxide (Other)
Acute exposure: Intermittent Hypoxia, Progressive Carbon Dioxide, Placebo
Study group will receive the three interventions in this order: Intermittent Hypoxia, Progressive Carbon Dioxide, Placebo
干预措施: Acute Intermittent Hypoxia (Other)
Acute exposure: Progressive Carbon Dioxide, Placebo, Intermittent Hypoxia
Study group will receive the three interventions in this order: Progressive Carbon Dioxide, Placebo, Intermittent Hypoxia
干预措施: Acute Placebo Visit (Other)
Acute exposure: Progressive Carbon Dioxide, Placebo, Intermittent Hypoxia
Study group will receive the three interventions in this order: Progressive Carbon Dioxide, Placebo, Intermittent Hypoxia
干预措施: Acute Progressive Carbon Dioxide (Other)
Acute exposure: Progressive Carbon Dioxide, Placebo, Intermittent Hypoxia
Study group will receive the three interventions in this order: Progressive Carbon Dioxide, Placebo, Intermittent Hypoxia
干预措施: Acute Intermittent Hypoxia (Other)
Acute exposure: Progressive Carbon Dioxide, Intermittent Hypoxia, Placebo
Study group will receive the three interventions in this order: Progressive Carbon Dioxide, Intermittent Hypoxia, Placebo
干预措施: Acute Placebo Visit (Other)
Acute exposure: Progressive Carbon Dioxide, Intermittent Hypoxia, Placebo
Study group will receive the three interventions in this order: Progressive Carbon Dioxide, Intermittent Hypoxia, Placebo
干预措施: Acute Progressive Carbon Dioxide (Other)
Acute exposure: Progressive Carbon Dioxide, Intermittent Hypoxia, Placebo
Study group will receive the three interventions in this order: Progressive Carbon Dioxide, Intermittent Hypoxia, Placebo
干预措施: Acute Intermittent Hypoxia (Other)
Placebo Group
Study group will complete 6 simulated cycles of 5 minutes breathing 21% oxygen from a douglas bag and 5 minutes breathing room air (60 minutes) for every visit during the 14 days intervention period. Subjects will then return within 7 days of their final training visit to repeat baseline testing
干预措施: Training: Placebo Control (Other)
Training Group
Training Study group will be complete 6 cycles of either progressive CO2 ramp protocol or the intermittent hypoxia protocol for 60 minutes for every visit during the 14 days. Subjects will then return within 7 days of their final training visit to repeat baseline testing
干预措施: Training: Progressive Carbon Dioxide Ramping (Other)
Training Group
Training Study group will be complete 6 cycles of either progressive CO2 ramp protocol or the intermittent hypoxia protocol for 60 minutes for every visit during the 14 days. Subjects will then return within 7 days of their final training visit to repeat baseline testing
干预措施: Training: Intermittent Hypoxic Exposure (Other)
结局指标
主要结局
Change in cerebral blood flow
时间窗: Baseline, post-acute exposure and 14 days post training
The intracranial middle cerebral arteries will be obtained (MCAv) will be imaged with a linear probe and duplex ultrasound system to simultaneously measure CBFv by pulse wave doppler (peak and mean flow)
Change in heart rate variability
时间窗: Baseline, post-acute exposure and 14 days post training
Short- term HRV analysis of a 3-lead ECG recording (5 minute recording) will evaluate both time-domain parameters (mean heart rate, standard deviation of normal-to-normal (NN) intervals (SDNN) and root mean square of successive differences between NN intervals rMSSD) and frequency-domain parameters (total power, high frequency (HF) and low frequency (LF) and LF/HF ratio).
Change in brain fog scale
时间窗: Baseline, post-acute exposure and 14 days post training
Questionnaire assessing of how much brain fog is affecting daily abilities
次要结局
- Change in fatigue functional assessment of chronic illness therapy-fatigue scale(Baseline, post-acute exposure and 14 days post training)
- Change in short form health survey (SF-36)(Baseline, post-acute exposure and 14 days post training)
- Change in Trail making test(Baseline, post-acute exposure and 14 days post training)
- Change in rapid cognitive assessment tool (RCAT) score(Baseline, post-acute exposure and 14 days post training)
- Change in Task switching test performance(Baseline, post-acute exposure and 14 days post training)
- Change in Rey Auditory Verbal Learning Test (AVLT) recall(Baseline, post-acute exposure and 14 days post training)
- Change in fatigue functional assessment of chronic illness therapy-fatigue scale(Baseline, post-acute exposure and 14 days post training)
- Change in short form health survey (SF-36)(Baseline, post-acute exposure and 14 days post training)
- Change in Trail making test(Baseline, post-acute exposure and 14 days post training)
- Change in rapid cognitive assessment tool (RCAT) score(Baseline, post-acute exposure and 14 days post training)
- Change in Task switching test performance(Baseline, post-acute exposure and 14 days post training)
- Change in Rey Auditory Verbal Learning Test (AVLT) recall(Baseline, post-acute exposure and 14 days post training)
研究者
Courtney M. Wheatley
Principal Investigator
Mayo Clinic