Colour Vision Impairment During Acute Hypobaric Hypoxia

Sponsor
Universitätsklinikum Köln (Other)
Overall Status
Completed
CT.gov ID
NCT05584813
Collaborator
(none)
54
1
5
37.5
1.4

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: Hypobaric Hypoxia
N/A

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)

Study Design

Study Type:
Interventional
Actual Enrollment :
54 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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)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)
Masking:
Single (Participant)
Masking Description:
Volunteers
Primary Purpose:
Basic Science
Official Title:
Randomized Controlled Trial for Evaluation of Colour Vision Impairment During Acute Hypobaric Hypoxia in Aviation Medicine
Actual Study Start Date :
Jul 1, 2019
Actual Primary Completion Date :
Nov 15, 2019
Actual Study Completion Date :
Aug 15, 2022

Arms and Interventions

Arm Intervention/Treatment
No Intervention: ground control binocular

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

No Intervention: ground control monocular

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

Experimental: 10,000 ft, 60 min, monocular pre-peri-post

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

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

Experimental: 15,000 ft, 15 min, binocular

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

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

Experimental: 15,000 ft, 60 min, monocular

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

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

Outcome Measures

Primary Outcome Measures

  1. Colour 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 variable

  2. Colour 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 variable

  3. Colour 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 variable

  4. Colour 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

  5. Colour 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 hypoxia

  6. Colour 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 hypoxia

  7. Colour 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 slightly

  8. 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 slightly

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospital Cologne Cologne North Rhine-Westphalia Germany 50937

Sponsors and Collaborators

  • Universitätsklinikum Köln

Investigators

  • Study Chair: Jochen Hinkelbein, Prof., University Hospital Cologne

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Universitätsklinikum Köln
ClinicalTrials.gov Identifier:
NCT05584813
Other Study ID Numbers:
  • DRU-COLOR-KOELN
First Posted:
Oct 18, 2022
Last Update Posted:
Oct 18, 2022
Last Verified:
Oct 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 18, 2022