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Colour Vision Impairment During Acute Hypobaric Hypoxia

Randomized Controlled Trial for Evaluation of Colour Vision Impairment During Acute Hypobaric Hypoxia in Aviation Medicine

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05584813
Enrollment
54
Registered
2022-10-18
Start date
2019-07-01
Completion date
2022-08-15
Last updated
2022-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypoxia, Altitude

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)

Interventions

The Waggoner Computerized Color Vision Test (WCCVT) and the Waggoner D-15 (WC-D15) were performed by 54 healthy volunteers in a decompression chamber.

Sponsors

Universitätsklinikum Köln
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Masking description

Volunteers

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)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* volunteers from 18 years old

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Colour vision pre hypoxia monocular/binocular Waggoner CCVTAssessment was conducted 15 minutes before the start of the hypoxia intervention and the number of correctly identified plates in the Waggoner CCVT was collectedWaggoner 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 D15Assessment was conducted 15 minutes before the start of the hypoxia intervention and S-Index, C-Index and TES in the Waggoner D15 were collectedWaggoner 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 during hypoxia monocular/binocular Waggoner CCVTAssessment was conducted immediately or 45 minutes after induction of hypoxia and the number of correctly identified plates in the Waggoner CCVT was collectedWaggoner 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 D15Assessment was conducted immediately or 45 minutes after induction of hypoxia and S-Index, C-Index and TES in the Waggoner D15 were collectedWaggoner 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
Colour vision after hypoxia monocular/binocular Waggoner CCVTAssessment was conducted immediately after hypoxia and the number of correctly identified plates in the Waggoner CCVT was collectedWaggoner 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 D15Assessment was conducted immediately after hypoxia and S-Index, C-Index and TES in the Waggoner D15 were collectedWaggoner 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 CCVTAssessment 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 collectedWaggoner 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 without hypoxia monocular/binocular D15Assessment 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 collectedWaggoner 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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026