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临床试验/NCT02125916
NCT02125916已完成不适用

Evaluating the Effect of Oxygentherapy on Concentration at Chronic Lung Patients

University of Aarhus2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2014年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
32
试验地点
2
主要终点
Response time

研究概览

简要总结

The objective is to study the cognitive functions in patients with chronic obstructive lung disease (COLD) and patients with interstitial lung disease (ILD) compared to healthy controls. The cognitive functions are tested with and without oxygen therapy to clarify the effect of oxygen therapy. Driving simulations is used to test the cognitive functions.

The hypothesis is that patients with chronic lung disease have decreased cognitive functions and that oxygen therapy will increase their cognitive functions.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • COLD with forced expiratory volume at one second (FEV1) <50%, without long term oxygen therapy
  • COLD with FEV1 <50%, with long term oxygen therapy
  • ILD with diffusion capacity of lung for carbon monoxide (DLCO) < 50%, without long term oxygen therapy

排除标准

  • comorbidity which decreases cognitive function
  • comorbidity which decreases concentration
  • physical comorbidity which makes it impossible to complete the test

结局指标

主要结局

Response time

时间窗: During the 45 min. of driving in the simulator

Measuring the mean amount of response time from the number "2" appears on the screen until the patient reacts

Standard deviation from the centre of the road

时间窗: During the 45 min. of driving in the simulator

Measuring how far from the centre of the road the patient has been driving in the driving simulation

Number of nil responses

时间窗: During the 45 min. of driving in the simulator

Measuring the number of times the patients doesn't react to the number "2" on the screen

Number of off-road events per hour

时间窗: During the 45 min. of driving in the simulator

The number of times the car is off-road during the driving simulation

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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