search
Back to results

Colour Vision Impairment During Acute Hypobaric Hypoxia

Primary Purpose

Hypoxia, Altitude

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Hypobaric Hypoxia
Sponsored by
Universitätsklinikum Köln
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hypoxia, Altitude

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • University Hospital Cologne

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

No Intervention

No Intervention

Experimental

Experimental

Experimental

Arm Label

ground control binocular

ground control monocular

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

15,000 ft, 15 min, binocular

15,000 ft, 60 min, monocular

Arm 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

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

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

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

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

Outcomes

Primary Outcome Measures

Colour vision pre hypoxia monocular/binocular Waggoner CCVT
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
Colour vision pre hypoxia monocular/binocular D15
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
Colour vision during hypoxia monocular/binocular Waggoner CCVT
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
Colour vision during hypoxia monocular/binocular D15
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
Colour vision after hypoxia monocular/binocular Waggoner CCVT
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
Colour vision after hypoxia monocular/binocular D15
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
Colour vision without hypoxia monocular/binocular Waggoner CCVT
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
Colour vision without hypoxia monocular/binocular D15
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

Secondary Outcome Measures

Full Information

First Posted
September 27, 2022
Last Updated
October 13, 2022
Sponsor
Universitätsklinikum Köln
search

1. Study Identification

Unique Protocol Identification Number
NCT05584813
Brief Title
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

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
November 15, 2019 (Actual)
Study Completion Date
August 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitätsklinikum Köln

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxia, Altitude

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Masking
Participant
Masking Description
Volunteers
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ground control binocular
Arm Type
No Intervention
Arm 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
Arm Title
ground control monocular
Arm Type
No Intervention
Arm 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
Arm Title
10,000 ft, 60 min, monocular pre-peri-post
Arm Type
Experimental
Arm 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
Arm Title
15,000 ft, 15 min, binocular
Arm Type
Experimental
Arm 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
Arm Title
15,000 ft, 60 min, monocular
Arm Type
Experimental
Arm 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
Intervention Type
Other
Intervention Name(s)
Hypobaric Hypoxia
Intervention Description
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 Outcome Measure Information:
Title
Colour vision pre hypoxia monocular/binocular Waggoner CCVT
Description
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
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
Title
Colour vision pre hypoxia monocular/binocular D15
Description
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
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
Title
Colour vision during hypoxia monocular/binocular Waggoner CCVT
Description
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
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
Title
Colour vision during hypoxia monocular/binocular D15
Description
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
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
Title
Colour vision after hypoxia monocular/binocular Waggoner CCVT
Description
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
Time Frame
Assessment was conducted immediately after hypoxia and the number of correctly identified plates in the Waggoner CCVT was collected
Title
Colour vision after hypoxia monocular/binocular D15
Description
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
Time Frame
Assessment was conducted immediately after hypoxia and S-Index, C-Index and TES in the Waggoner D15 were collected
Title
Colour vision without hypoxia monocular/binocular Waggoner CCVT
Description
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
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
Title
Colour vision without hypoxia monocular/binocular D15
Description
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
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jochen Hinkelbein, Prof.
Organizational Affiliation
University Hospital Cologne
Official's Role
Study Chair
Facility Information:
Facility Name
University Hospital Cologne
City
Cologne
State/Province
North Rhine-Westphalia
ZIP/Postal Code
50937
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

Colour Vision Impairment During Acute Hypobaric Hypoxia

We'll reach out to this number within 24 hrs