Clinical trial NCT05584813: Colour Vision Impairment During Acute Hypobaric Hypoxia
Official title: Randomized Controlled Trial for Evaluation of Colour Vision Impairment During Acute Hypobaric Hypoxia in Aviation Medicine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypoxia, Altitude
Lead sponsor: Universitätsklinikum Köln
Sponsor class: OTHER
First posted: 2022-10-18
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Five different Groups were analyzed:

* 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)
Primary purpose: BASIC_SCIENCE

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)

Eligibility criteria: Inclusion Criteria:

* volunteers from 18 years old

Exclusion Criteria:

* cardiovascular, pulmonary, neurological, or ear, nose, and throat disease
* pregnant or suffering from cold symptoms

Primary outcomes:
measure: Colour vision pre hypoxia monocular/binocular Waggoner CCVT
timeFrame: 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
measure: Colour vision pre hypoxia monocular/binocular D15
timeFrame: 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
measure: Colour vision during hypoxia monocular/binocular Waggoner CCVT
timeFrame: Assessment was conducted immediately or 45 minutes after induction of hypoxia and the number of correctly identified plates in the Waggoner CCVT was collected
measure: Colour vision during hypoxia monocular/binocular D15
timeFrame: Assessment was conducted immediately or 45 minutes after induction of hypoxia and S-Index, C-Index and TES in the Waggoner D15 were collected
measure: Colour vision after hypoxia monocular/binocular Waggoner CCVT
timeFrame: Assessment was conducted immediately after hypoxia and the number of correctly identified plates in the Waggoner CCVT was collected
measure: Colour vision after hypoxia monocular/binocular D15
timeFrame: Assessment was conducted immediately after hypoxia and S-Index, C-Index and TES in the Waggoner D15 were collected
measure: Colour vision without hypoxia monocular/binocular Waggoner CCVT
timeFrame: 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
measure: Colour vision without hypoxia monocular/binocular D15
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: University Hospital Cologne
state: North Rhine-Westphalia
Study officials:
affiliation: University Hospital Cologne
name: Jochen Hinkelbein, Prof.
role: STUDY_CHAIR
References: