Pilot Open Label Use of the Hi-OXSR to Increase PaCO2 for the Treatment of Post COVID-19 Cognitive Dysfunction
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Safety of use of Hi-OX sequential rebreathing device
研究概览
简要总结
During the worldwide COVID-19 pandemic a large number patients reported different functional complaints one month or later after recovery from the acute infection. This entity had a number of names including "long-COVID" or "post COVID condition". Long-COVID is on the rise and no effective treatment exists yet to improve cognitive function. Recent research has shown that people with even mild COVID had a greater decline in executive function, notably in their ability to perform complex tasks. What drives post-COVID cognitive changes is still a mystery and there are no effective treatments available. One hypothesis is that there is persistent immune activation resulting in reduction in cerebral blood flow. There is evidence that increased CO2 may decrease inflammation, and decreased CO2 may increase inflammation.
Objectives: The primary objective of this pilot study is to assess the safety and tolerability of the use of Hi-OX sequential rebreathing for the treatment of post-COVID cognitive dysfunction. The secondary objective is to identify the effects of the use of the Hi-OX rebreathing treatment in changing post-COVID cognitive dysfunction.
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
- •Ability to provide written informed consent.
- •Previously diagnosed with cognitive dysfunction following recovery from COVID.
- •Not pregnant at time of study.
- •Oxygen saturation on room air ≥92% at screening.
- •Willing and able to comply with the treatment schedule and procedures.
排除标准
- •History of cognitive dysfunction prior to COVID infection
- •Hospitalization for the treatment of COVID
- •Participating in another investigational trial or the use of an investigational drug within 30 days of screening
- •For individuals of childbearing potential:
- •positive pregnancy test at screening or lactating or unwilling to practice a medically acceptable form of contraception from screening to Day 14 (acceptable forms of contraception: abstinence, hormonal birth control, intrauterine device, or barrier method plus a spermicidal agent)
- •History of pulmonary hypertension
- •History of narcolepsy
- •Moderate to severe COPD
- •Interstitial Pulmonary Fibrosis
- •End-tidal PCO2 >55 mmHg during training treatment
- •Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the subject or the quality of the data
结局指标
主要结局
Safety of use of Hi-OX sequential rebreathing device
时间窗: 45 days
Any unanticipated adverse events reporting
次要结局
未报告次要终点