Colour Vision Impairment During Acute Hypobaric Hypoxia
- Conditions
- Hypoxia, Altitude
- Interventions
- Other: Hypobaric Hypoxia
- Registration Number
- NCT05584813
- Lead Sponsor
- Universitätsklinikum Köln
- Brief Summary
This study analyses the impairment of colour vision during hypobaric hypoxia in volunteers of different groups.
- Detailed Description
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)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 54
- volunteers from 18 years old
- cardiovascular, pulmonary, neurological, or ear, nose, and throat disease
- pregnant or suffering from cold symptoms
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 10,000 ft, 60 min, monocular pre-peri-post Hypobaric Hypoxia Intervention: Hypoxia equivalent to an altitude of 10.000 ft. for 60 minutes Procedures: Colour vision tests were performed with one eye at a time, thereby: * pre intervention with no hypoxia administered * during intervention with hypoxia equivalent to an altitude of 10.000 ft. for 60 minutes * post intervention with no hypoxia administered 15,000 ft, 60 min, monocular Hypobaric Hypoxia Intervention: Hypoxia equivalent to an altitude of 15.000 ft. for 60 minutes Procedures: Colour vision tests were performed with one eye at a time, thereby: * pre intervention with no hypoxia administered * during intervention with hypoxia equivalent to an altitude of 15.000 ft. for 60 minutes * post intervention with no hypoxia administered 15,000 ft, 15 min, binocular Hypobaric Hypoxia Intervention: Hypoxia equivalent to an altitude of 15.000 ft. for 15 minutes Procedures: Colour vision tests were performed with both eyes, thereby: * pre intervention with no hypoxia administered * during intervention with hypoxia equivalent to an altitude of 15000 ft. for 15 minutes * post intervention with no hypoxia administered
- Primary Outcome Measures
Name Time Method Colour vision without hypoxia monocular/binocular D15 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 slightlyColour vision pre hypoxia monocular/binocular Waggoner CCVT 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 variableColour vision pre hypoxia monocular/binocular D15 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 variableColour vision after hypoxia monocular/binocular Waggoner CCVT 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 hypoxiaColour vision after hypoxia monocular/binocular D15 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 hypoxiaColour vision without hypoxia monocular/binocular Waggoner CCVT 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 slightlyColour vision during hypoxia monocular/binocular Waggoner CCVT 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 variableColour vision during hypoxia monocular/binocular D15 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University Hospital Cologne
🇩🇪Cologne, North Rhine-Westphalia, Germany