Hypoxia, AltitudeNCT05584813
Colour Vision Impairment During Acute Hypobaric Hypoxia
A study testing Hypobaric Hypoxia in people with Hypoxia, Altitude, run by Universitätsklinikum Köln at 1 site in Germany.
Trial summary
This study analyses the impairment of colour vision during hypobaric hypoxia in volunteers of different groups. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypoxia, Altitude
- What is being tested?
- Hypobaric Hypoxia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jul 2019to 15 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- volunteers from 18 years old
Who cannot join
- cardiovascular, pulmonary, neurological, or ear, nose, and throat disease
- pregnant or suffering from cold symptoms
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Cologne
Cologne, North Rhine-Westphalia, 50937
About this study
Official title: Randomized Controlled Trial for Evaluation of Colour Vision Impairment During Acute Hypobaric Hypoxia in Aviation Medicine
This study analyses the impairment of colour vision during hypobaric hypoxia in volunteers of different groups.
Read the 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)
- Conditions
- Hypoxia, Altitude
- Being tested
- Hypobaric Hypoxia
- Medical subject headings
- Altitude Sickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypobaric HypoxiaOther
The Waggoner Computerized Color Vision Test (WCCVT) and the Waggoner D-15 (WC-D15) were performed by 54 healthy volunteers in a decompression chamber.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Other: Hypobaric Hypoxia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2022
- Study start1 Jul 2019
- Primary completion15 Nov 2019
- Study completion15 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoxia, AltitudeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Köln
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jochen Hinkelbein, Prof., Study chair, University Hospital of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05584813
- Sponsor's protocol ID
- DRU-COLOR-KOELN
- Status last verified
- Oct 2022
- First submitted
- 27 Sep 2022
- Last updated
- 18 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial for Evaluation of Colour Vision Impairment During Acute Hypobaric Hypoxia in Aviation Medicine
- ClinicalTrials.gov ID
- NCT05584813
- Acronym / sponsor ID
- DRU-COLOR-KOELN
- Conditions
- Hypoxia, Altitude
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Universitätsklinikum KölnUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 15 Nov 2019 (actual)
- Study completion
- 15 Aug 2022 (actual)
- First posted
- 18 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 5
- 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)
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Hypobaric HypoxiaIntervention: 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 |
| 15,000 ft, 15 min, binocular | Experimental | Other: Hypobaric HypoxiaIntervention: 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 |
| 15,000 ft, 60 min, monocular | Experimental | Other: Hypobaric HypoxiaIntervention: 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- volunteers from 18 years old
Key exclusion criteria (2 listed)
- cardiovascular, pulmonary, neurological, or ear, nose, and throat disease
- pregnant or suffering from cold symptoms
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypobaric HypoxiaThe Waggoner Computerized Color Vision Test (WCCVT) and the Waggoner D-15 (WC-D15) were performed by 54 healthy volunteers in a decompression chamber. | Other | 10,000 ft, 60 min, monocular pre-peri-post, 15,000 ft, 15 min, binocular, 15,000 ft, 60 min, monocular |
Primary outcome
Colour vision pre hypoxia monocular/binocular Waggoner CCVT
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
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
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
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
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
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
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
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
Time frame: 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
Colour vision after hypoxia monocular/binocular D15
Time frame: 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
Colour vision without hypoxia monocular/binocular Waggoner CCVT
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jochen Hinkelbein, Prof. study chair
University Hospital of Cologne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypobaric Hypoxia in people with Hypoxia, Altitude, run by Universitätsklinikum Köln at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Colour vision pre hypoxia monocular/binocular Waggoner CCVT (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). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2022.