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Completed

NCT Number: NCT05584813

Colour Vision Impairment During Acute Hypobaric Hypoxia

This study analyses the impairment of colour vision during hypobaric hypoxia in volunteers of different groups.

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Key information

Conditions

Hypoxia, Altitude Altitude Sickness Respiration Disorders Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Cologne

Cologne, North Rhine-Westphalia, 50937, Germany

About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • volunteers from 18 years old

Exclusion criteria

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

Treatment and study plan

Hypobaric Hypoxia

Other

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

Primary outcomes

  1. Colour vision pre hypoxia monocular/binocular Waggoner CCVT

    Time frame: 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

  2. Colour vision pre hypoxia monocular/binocular D15

    Time frame: 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

  3. Colour vision during hypoxia monocular/binocular Waggoner CCVT

    Time frame: 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

  4. Colour vision during hypoxia monocular/binocular D15

    Time frame: 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

  5. Colour vision after hypoxia monocular/binocular Waggoner CCVT

    Time frame: 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

  6. Colour vision after hypoxia monocular/binocular D15

    Time frame: 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

  7. Colour vision without hypoxia monocular/binocular Waggoner CCVT

    Time frame: 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

  8. Colour vision without hypoxia monocular/binocular D15

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Köln

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2022
First posted
Oct 18, 2022
Registry last updated
Oct 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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