Colour Vision Impairment During Acute Hypobaric Hypoxia

NCT05584813 | Completed

• 1 other identifier: DRU-COLOR-KOELN
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypoxia, Altitude

Outcome Measures

Primary Outcomes (8)

• 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

  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

• 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

  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

• 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

  Assessment was conducted immediately or 45 minutes after induction of hypoxia and the number of correctly identified plates in the Waggoner CCVT was collected

• 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

  Assessment was conducted immediately or 45 minutes after induction of hypoxia and S-Index, C-Index and TES in the Waggoner D15 were collected

• 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

  Assessment was conducted immediately after hypoxia and the number of correctly identified plates in the Waggoner CCVT was collected

• 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

  Assessment was conducted immediately after hypoxia and S-Index, C-Index and TES in the Waggoner D15 were collected

• 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

  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

• 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

  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

Study Arms (5)

ground control binocular

NO INTERVENTION

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

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

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

15,000 ft, 15 min, binocular

EXPERIMENTAL

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

15,000 ft, 60 min, monocular

EXPERIMENTAL

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

Interventions

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.

10,000 ft, 60 min, monocular pre-peri-post; 15,000 ft, 15 min, binocular; 15,000 ft, 60 min, monocular

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• volunteers from 18 years old

You may not qualify if:

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

Sponsors & Collaborators

• Universitätsklinikum Köln: lead

Study Sites (1)

University Hospital Cologne

Cologne, North Rhine-Westphalia, 50937, Germany

Location

MeSH Terms

Conditions

Altitude Sickness

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Jochen Hinkelbein, Prof.

  University Hospital Cologne

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Volunteers
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: September 27, 2022
• First Posted: October 18, 2022
• Study Start: July 1, 2019
• Primary Completion: November 15, 2019
• Study Completion: August 15, 2022
• Last Updated: October 18, 2022

Record last verified: 2022-10

Locations

DE (1)