Effect of Supplemental Oxygen Therapy on Neurocognitive Performance in Healthy Highlanders
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- Psychomotor vigilance reaction time
研究概览
简要总结
Exposure to high altitudes, defined as locations above 2500 m, has been shown to cause cognitive alternations due to reduced blood oxygenation (SpO2). However, it remains to be determined whether cognitive changes are present in highlanders living at moderate altitudes (2500 m) and whether cognitive alterations are reversible with supplemental oxygen therapy (SOT).
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)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed written consent
- •Kyrgyz ethnicity
- •Born, raised and living at approximately 2500 m
- •Native or fluent in Russian language
排除标准
- •Severe disease such as unstable hypertension, coronary heart disease, pulmonary diseases, others.
- •Regular use of medication that interfere with sleep or breathing such as benzodiazepines, opioids, acetazolamide
- •Heavy smoking of >20 cigarettes per day
- •Not able to read or adhere to the study protocol
研究组 & 干预措施
SOT followed by Sham intervention
5L /min supplemental oxygen therapy through a nasal canula will be administered to the participants. The intervention will start 5 minutes before the neurocognitive assessments and will be administered throughout the assessment. After >4 hours of washout, the participants will repeat the neurocognitive assessments with 5 L/min sham intervention (room air).
干预措施: Supplemental oxygen therapy (Drug)
SOT followed by Sham intervention
5L /min supplemental oxygen therapy through a nasal canula will be administered to the participants. The intervention will start 5 minutes before the neurocognitive assessments and will be administered throughout the assessment. After >4 hours of washout, the participants will repeat the neurocognitive assessments with 5 L/min sham intervention (room air).
干预措施: Sham intervention (Other)
Sham intervention followed by SOT
5L /min sham intervention (room air) through a nasal canula will be administered to the participants. The intervention will start 5 minutes before the neurocognitive assessments and will be administered throughout the assessment. After >4 hours of washout, the participants will repeat the neurocognitive assessments with 5 L/min supplemental oxygen therapy.
干预措施: Sham intervention (Other)
Sham intervention followed by SOT
5L /min sham intervention (room air) through a nasal canula will be administered to the participants. The intervention will start 5 minutes before the neurocognitive assessments and will be administered throughout the assessment. After >4 hours of washout, the participants will repeat the neurocognitive assessments with 5 L/min supplemental oxygen therapy.
干预措施: Supplemental oxygen therapy (Drug)
结局指标
主要结局
Psychomotor vigilance reaction time
时间窗: Comparison between SOT and sham after 15 minutes intervention
The difference in the reaction time during a 10-minute psychomotor vigilance test between SOT and Sham intervention.
次要结局
- Trail making test performance(Comparison between SOT and sham after 15 minutes intervention)
- Stroop test performance(Comparison between SOT and sham after 15 minutes intervention)
- Digit Span test performance(Comparison between SOT and sham after 15 minutes intervention)
- Go / No-Go test performance(Comparison between SOT and sham after 15 minutes intervention)
- N-back test performance(Comparison between SOT and sham after 15 minutes intervention)
- Task Switching Cued test performance(Comparison between SOT and sham after 15 minutes intervention)
- Flanker test performance(Comparison between SOT and sham after 15 minutes intervention)
- Corsi Span test performance(Comparison between SOT and sham after 15 minutes intervention)