Colour Vision Impairment During Acute Hypobaric Hypoxia

Hypoxia, Altitude Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05584813
• Other study ID #: DRU-COLOR-KOELN
• Status: Completed
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: August 15, 2022

Study information

• Verified date: October 2022
• Source: Universitätsklinikum Köln
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: August 15, 2022
• Est. primary completion date: November 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• volunteers from 18 years old

Exclusion Criteria:

• cardiovascular, pulmonary, neurological, or ear, nose, and throat disease

• pregnant or suffering from cold symptoms

Related Conditions & MeSH terms

• Altitude Sickness
• Hypoxia
• Hypoxia, Altitude

Intervention

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.

Locations

Country	Name	City	State
Germany	University Hospital Cologne	Cologne	North Rhine-Westphalia

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Köln

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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