Effect of Supplemental Oxygen Therapy on Neurocognitive Performance in Healthy Highlanders (SPIRIT_1)
2026年6月10日 更新者：University of Zurich
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).
研究概览
研究类型
介入性
注册 (估计的)
50
阶段
- 第四阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Michael Furian, Prof. Dr.
- 电话号码：+41794037586
- 邮箱：michael.furian@usz.ch
研究联系人备份
- 姓名：Edith M Schneider, Dr.
- 邮箱：edith.schneidergasser@usz.ch
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
是的
描述
Inclusion Criteria:
- Signed written consent
- Age >18
- Kyrgyz ethnicity
- Born, raised and living at approximately 2500 m
- Native or fluent in Russian language
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：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).
|
5 L/min supplemental oxygen therapy administered through nasal canula.
5 L/min sham intervention administered through nasal canula.
|
|
假比较器：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.
|
5 L/min supplemental oxygen therapy administered through nasal canula.
5 L/min sham intervention administered through nasal canula.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Psychomotor vigilance reaction time
大体时间：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.
|
Comparison between SOT and sham after 15 minutes intervention
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Trail making test performance
大体时间：Comparison between SOT and sham after 15 minutes intervention
|
The difference in the trial making test A performance between SOT and Sham intervention.
|
Comparison between SOT and sham after 15 minutes intervention
|
|
Stroop test performance
大体时间：Comparison between SOT and sham after 15 minutes intervention
|
The difference in the stroop test performance between SOT and Sham intervention.
|
Comparison between SOT and sham after 15 minutes intervention
|
|
Digit Span test performance
大体时间：Comparison between SOT and sham after 15 minutes intervention
|
The difference in the digit span test performance between SOT and Sham intervention.
|
Comparison between SOT and sham after 15 minutes intervention
|
|
Go / No-Go test performance
大体时间：Comparison between SOT and sham after 15 minutes intervention
|
The difference in the Go / No-Go test performance between SOT and Sham intervention.
|
Comparison between SOT and sham after 15 minutes intervention
|
|
N-back test performance
大体时间：Comparison between SOT and sham after 15 minutes intervention
|
The difference in the n-back test performance between SOT and Sham intervention.
|
Comparison between SOT and sham after 15 minutes intervention
|
|
Task Switching Cued test performance
大体时间：Comparison between SOT and sham after 15 minutes intervention
|
The difference in the task switching cued test performance between SOT and Sham intervention.
|
Comparison between SOT and sham after 15 minutes intervention
|
|
Flanker test performance
大体时间：Comparison between SOT and sham after 15 minutes intervention
|
The difference in the Flanker test performance between SOT and Sham intervention.
|
Comparison between SOT and sham after 15 minutes intervention
|
|
Corsi Span test performance
大体时间：Comparison between SOT and sham after 15 minutes intervention
|
The difference in the Corsi span test performance between SOT and Sham intervention.
|
Comparison between SOT and sham after 15 minutes intervention
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Michael Furian、University of Zurich
- 首席研究员：Edith M Schneider, Dr.、University of Zurich
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年6月18日
初级完成 (估计的)
2026年7月31日
研究完成 (估计的)
2026年7月31日
研究注册日期
首次提交
2026年6月3日
首先提交符合 QC 标准的
2026年6月10日
首次发布 (实际的)
2026年6月16日
研究记录更新
最后更新发布 (实际的)
2026年6月16日
上次提交的符合 QC 标准的更新
2026年6月10日
最后验证
2026年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.