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Colour Vision Impairment During Acute Hypobaric Hypoxia

U

Universitätsklinikum Köln

Status

Completed

Conditions

Hypoxia, Altitude

Treatments

Other: Hypobaric Hypoxia

Study type

Interventional

Funder types

Other

Identifiers

NCT05584813
DRU-COLOR-KOELN

Details and patient eligibility

About

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

Full 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)

Enrollment

54 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • volunteers from 18 years old

Exclusion criteria

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

54 participants in 5 patient groups

ground control binocular
No Intervention group
Description:
Intervention: pressure chamber environment Procedures: Colour vision tests were performed under normoxia with both eyes three times in a row for appropriate comparability to the simulated flight stages pre-peri-post hypoxia in the intervention groups
ground control monocular
No Intervention group
Description:
Intervention: pressure chamber environment Procedures: Colour vision tests were performed under normoxia with one eye at a time three times in a row for appropriate comparability to the simulated flight stages pre-peri-post hypoxia in the intervention groups
10,000 ft, 60 min, monocular pre-peri-post
Experimental group
Description:
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
Treatment:
Other: Hypobaric Hypoxia
15,000 ft, 15 min, binocular
Experimental group
Description:
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
Treatment:
Other: Hypobaric Hypoxia
15,000 ft, 60 min, monocular
Experimental group
Description:
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
Treatment:
Other: Hypobaric Hypoxia

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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