Colour Vision Impairment During Acute Hypobaric Hypoxia

NCT ID: NCT05584813

Last Updated: 2022-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-01

Study Completion Date

2022-08-15

Brief Summary

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

Detailed Description

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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)

Conditions

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Hypoxia, Altitude

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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)
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants
Volunteers

Study Groups

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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

Group Type NO_INTERVENTION

No interventions assigned to this group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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

Group Type EXPERIMENTAL

Hypobaric Hypoxia

Intervention Type 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.

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

Group Type EXPERIMENTAL

Hypobaric Hypoxia

Intervention Type 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.

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

Group Type EXPERIMENTAL

Hypobaric Hypoxia

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* volunteers from 18 years old

Exclusion Criteria

* cardiovascular, pulmonary, neurological, or ear, nose, and throat disease
* pregnant or suffering from cold symptoms
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universitätsklinikum Köln

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jochen Hinkelbein, Prof.

Role: STUDY_CHAIR

University Hospital Cologne

Locations

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University Hospital Cologne

Cologne, North Rhine-Westphalia, Germany

Site Status

Countries

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Germany

Other Identifiers

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DRU-COLOR-KOELN

Identifier Type: -

Identifier Source: org_study_id

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