Randomized Controlled Trial for Evaluation of Colour Vision Impairment During Acute Hypobaric Hypoxia in Aviation Medicine
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Colour vision without hypoxia monocular/binocular D15
研究概览
简要总结
This study analyses the impairment of colour vision during hypobaric hypoxia in volunteers of different groups.
详细描述
This study analyses the impairment of colour vision during hypobaric hypoxia in volunteers of different groups.
Five different Groups were analysed:
- ground control binocular (n=12, Bi/GC)
- ground control monocular (n=11, Mo/GC)
- 10,000 ft, 60 min, monocular (n=10, Mo/60/10,000)
- 15,000 ft, 15 min, binocular (n=11, Bi/15/15,000)
- 15,000 ft, 60 min, monocular (n=10, Mo/60/15,000)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
盲法说明
Volunteers
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
- •volunteers from 18 years old
排除标准
- •cardiovascular, pulmonary, neurological, or ear, nose, and throat disease
- •pregnant or suffering from cold symptoms
结局指标
主要结局
Colour vision without hypoxia monocular/binocular D15
时间窗: Assessment was coducted independently of hypoxia three times in a row with a 1 minute break in between each test, and S-Index, C-Index and TES in the Waggoner D15 were collected
Waggoner D15 was administered three times in a row without hypoxia, thereby the following parameters were collected: - S-Index, C-Index and TES in the Waggoner D15 as of the study arm "ground control binocular" the colour vision tests were performed binocularly as of the study arm "ground control monocular" the colour vision tests were performed monocularly Time Frame - additional info: - depending on the time the subjects took for each of the colour vision tests, total duration of all 3 test sequences can differ slightly
Colour vision pre hypoxia monocular/binocular Waggoner CCVT
时间窗: Assessment was conducted 15 minutes before the start of the hypoxia intervention and the number of correctly identified plates in the Waggoner CCVT was collected
Waggoner CCVT was administered in the pressure chamber pre hypoxia intervention, thereby the following parameters were collected: - the number of correctly identified plates in the Waggoner CCVT as of the study arm "15,000 ft, 15 min, binocular" the colour vision tests were performed binocularly as of the study arms "15,000 ft, 60 min, monocular" and "10,000 ft, 60 min, monocular" the colour vision tests were performed monocularly Time Frame - additional info: - depending on the time the subjects took for the colour vision tests, the time between the end of the pre-test and the onset of hypoxia was slightly variable
Colour vision pre hypoxia monocular/binocular D15
时间窗: Assessment was conducted 15 minutes before the start of the hypoxia intervention and S-Index, C-Index and TES in the Waggoner D15 were collected
Waggoner D15 was administered in the pressure chamber pre hypoxia intervention, thereby the following parameters were collected: - S-Index, C-Index and TES in the Waggoner D15 as of the study arm "15,000 ft, 15 min, binocular" the colour vision tests were performed binocularly as of the study arms "15,000 ft, 60 min, monocular" and "10,000 ft, 60 min, monocular" the colour vision tests were performed monocularly Time Frame - additional info: depending on the time the subjects took for the colour vision tests, the time between the end of the pre-test and the onset of hypoxia was slightly variable
Colour vision after hypoxia monocular/binocular Waggoner CCVT
时间窗: Assessment was conducted immediately after hypoxia and the number of correctly identified plates in the Waggoner CCVT was collected
Waggoner CCVT was administered in the pressure chamber post hypoxia intervention, thereby the following parameters were collected: - the number of correctly identified plates in the Waggoner CCVT as of the study arm "15,000 ft, 15 min, binocular" the colour vision tests were performed binocularly as of the study arms "15,000 ft, 60 min, monocular" and "10,000 ft, 60 min, monocular" the colour vision tests were performed monocularly Time Frame - additional info: * as of the study arm "15,000 ft, 15 min, binocular" assessment was conducted immediately after 15min of hypoxia * as of the study arms "15,000 ft, 60 min, monocular" and "10,000 ft, 60 min, monocular" assessment was conducted immediately after 60 minutes of hypoxia
Colour vision after hypoxia monocular/binocular D15
时间窗: Assessment was conducted immediately after hypoxia and S-Index, C-Index and TES in the Waggoner D15 were collected
Waggoner D15 was administered in the pressure chamber post hypoxia intervention, thereby the following parameters were collected: - S-Index, C-Index and TES in the Waggoner D15 as of the study arm "15,000 ft, 15 min, binocular" the colour vision tests were performed binocularly as of the study arms "15,000 ft, 60 min, monocular" and "10,000 ft, 60 min, monocular" the colour vision tests were performed monocularly Time Frame - additional info: * as of the study arm "15,000 ft, 15 min, binocular" assessment was conducted immediately after 15min of hypoxia * as of the study arms "15,000 ft, 60 min, monocular" and "10,000 ft, 60 min, monocular" assessment was conducted immediately after 60 minutes of hypoxia
Colour vision without hypoxia monocular/binocular Waggoner CCVT
时间窗: Assessment was coducted independently of hypoxia three times in a row with a 1 minute break in between each test and the number of correctly identified plates in the Waggoner CCVT was collected
Waggoner CCVT was administered three times in a row without hypoxia, thereby the following parameters were collected: - the number of correctly identified plates in the Waggoner CCVT as of the study arm "ground control binocular" the colour vision tests were performed binocularly as of the study arm "ground control monocular" the colour vision tests were performed monocularly Time Frame - additional info: - depending on the time the subjects took for each of the colour vision tests, total duration of all 3 test sequences can differ slightly
Colour vision during hypoxia monocular/binocular Waggoner CCVT
时间窗: Assessment was conducted immediately or 45 minutes after induction of hypoxia and the number of correctly identified plates in the Waggoner CCVT was collected
Waggoner CCVT was administered in the pressure chamber during hypoxia intervention, thereby the following parameters were collected: - the number of correctly identified plates in the Waggoner CCVT as of the study arm "15,000 ft, 15 min, binocular" the colour vision tests were performed binocularly as of the study arms "15,000 ft, 60 min, monocular" and "10,000 ft, 60 min, monocular" the colour vision tests were performed monocularly Time Frame - additional info: * as of the study arm "15,000 ft, 15 min, binocular" assessment was conducted immediately after onset of hypoxia * as of the study arms "15,000 ft, 60 min, monocular" and "10,000 ft, 60 min, monocular" assessment was conducted 45 minutes after onset of hypoxia * depending on the time the subjects took for the colour vision tests, the time between the end of the peri-test and the end of hypoxia was slightly variable
Colour vision during hypoxia monocular/binocular D15
时间窗: Assessment was conducted immediately or 45 minutes after induction of hypoxia and S-Index, C-Index and TES in the Waggoner D15 were collected
Waggoner D15 was administered in the pressure chamber during hypoxia intervention, thereby the following parameters were collected: - S-Index, C-Index and TES in the Waggoner D15 as of the study arm "15,000 ft, 15 min, binocular" the colour vision tests were performed binocularly as of the study arms "15,000 ft, 60 min, monocular" and "10,000 ft, 60 min, monocular" the colour vision tests were performed monocularly Time Frame - additional info: * as of the study arm "15,000 ft, 15 min, binocular" assessment was conducted immediately after onset of hypoxia * as of the study arms "15,000 ft, 60 min, monocular" and "10,000 ft, 60 min, monocular" assessment was conducted 45 minutes after onset of hypoxia * depending on the time the subjects took for the colour vision tests, the time between the end of the peri-test and the end of hypoxia was slightly variable
次要结局
未报告次要终点