Effect of High AltitudeNCT02731456
Effect of High Altitude Exposure, Acclimatization and Re-exposure on Psychomotor Performance in Lowlanders
A study testing altitude exposure in people with Effect of High Altitude, run by Marc Poulin at 1 site in Canada.
Trial summary
Prospective interventional trial in lowlanders evaluating the effect of acute exposure, acclimatization and re-exposure to high altitude on psychomotor vigilance to measure sustained attention. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Effect of High Altitude
- What is being tested?
- altitude exposure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteCanada
- Study dates
- 1 Mar 2016to 31 Dec 2017
- 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 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- born, raised and currently living <1300m
- No overnight stays at altitudes >1500m 4 weeks before the study
Who cannot join
- previous altitude intolerance <3000m
- pregnancy
- health impairment, which requires regular treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of High Altitude Exposure, Acclimatization and Re-exposure on Psychomotor Performance and Sleep Quality in Lowlanders
Prospective interventional trial in lowlanders evaluating the effect of acute exposure, acclimatization and re-exposure to high altitude on psychomotor vigilance to measure sustained attention.
Read the detailed description
Baseline measurements will be performed in Santiago de Chile, 520 m, over the course of 3 days. Participants will then travel by commercial airline (2 h flight) and by bus (2 h ride) to the ALMA base camp located at 2900 m near San Pedro de Atacama, northern Chile. Participants will stay there for the next 7 nights and they will spend the days (6 total; 6-8 h daily) at the telescope station at 5050 m while undergoing testing as described above at the first and the last day at 5050m. Daily transports from 2900 to 5050 m will be by car (1 h ride, one way). After the first 7 day altitude sojourn participants will return to the Santiago area (520 m) for a 7 day recovery period. A second altitude sojourn with an identical schedule as the one described above and a final low altitude stay of 3 days will follow.
- Conditions
- Effect of High Altitude
- Being tested
- altitude exposure
- Keywords
- high altitude, cognition, sleep
- Medical subject headings
- Altitude Sickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
altitude exposureOther
altitude exposure
| Study group | Role | What they receive |
|---|---|---|
| Altitude exposure | Experimental | Acute high altitude exposure followed by 8 day acclimatization and re-exposure for 8 days after 6 days at low altitude. Receives: Other: altitude exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained attention measured by a visual pychomotor vigilance test (PVT)
Change in psychomotor response speed across two cycles of altitude exposure, comparing 5050m to 520m.
Measured: Low altitude dojourn at 520m; forst sojourn at 5050m Day 2, 7; second sojourn at 5050m Day 2, 7
Secondary outcomes (1)
Indices of sleep quality measured by actigraphy (total sleep time, sleep efficiency, sleep latency
Measured: Low altitude dojourn at 520m; forst sojourn at 5050m Day 2, 7; second sojourn at 5050m Day 2, 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2016 (estimated)
- Study start1 Mar 2016
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effect of High 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marc Poulin
- Sponsor type
- University, hospital or other
- Collaborators
- University of Zurich
- Responsible party
- Sponsor-investigator, Marc Poulin, University of Calgary
- Investigators
- Marc J Poulin, PhD, DPhil, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02731456
- Sponsor's protocol ID
- REB15 - 2709_MOD1
- Status last verified
- Apr 2018
- First submitted
- 3 Apr 2016
- Last updated
- 25 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of High Altitude Exposure, Acclimatization and Re-exposure on Psychomotor Performance and Sleep Quality in Lowlanders
- ClinicalTrials.gov ID
- NCT02731456
- Acronym / sponsor ID
- REB15 - 2709_MOD1
- Conditions
- Effect of High Altitude
- Keywords
- high altitude, cognition, sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Marc PoulinUniversity, hospital or other
- Collaborators
- University of Zurich
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 7 Apr 2016 (estimated)
- 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.
Prospective interventional trial in lowlanders evaluating the effect of acute exposure, acclimatization and re-exposure to high altitude on psychomotor vigilance to measure sustained attention.
Detailed description
Baseline measurements will be performed in Santiago de Chile, 520 m, over the course of 3 days. Participants will then travel by commercial airline (2 h flight) and by bus (2 h ride) to the ALMA base camp located at 2900 m near San Pedro de Atacama, northern Chile. Participants will stay there for the next 7 nights and they will spend the days (6 total; 6-8 h daily) at the telescope station at 5050 m while undergoing testing as described above at the first and the last day at 5050m. Daily transports from 2900 to 5050 m will be by car (1 h ride, one way). After the first 7 day altitude sojourn participants will return to the Santiago area (520 m) for a 7 day recovery period. A second altitude sojourn with an identical schedule as the one described above and a final low altitude stay of 3 days will follow.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Altitude exposure | Experimental | Other: altitude exposureAcute high altitude exposure followed by 8 day acclimatization and re-exposure for 8 days after 6 days at low altitude. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- born, raised and currently living <1300m
- No overnight stays at altitudes >1500m 4 weeks before the study
Key exclusion criteria (3 listed)
- previous altitude intolerance <3000m
- pregnancy
- health impairment, which requires regular treatment
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 |
|---|---|---|
| altitude exposurealtitude exposure | Other | Altitude exposure |
Primary outcome
Sustained attention measured by a visual pychomotor vigilance test (PVT)
Time frame: Low altitude dojourn at 520m; forst sojourn at 5050m Day 2, 7; second sojourn at 5050m Day 2, 7
Change in psychomotor response speed across two cycles of altitude exposure, comparing 5050m to 520m.
1 secondary outcome
Indices of sleep quality measured by actigraphy (total sleep time, sleep efficiency, sleep latency
Time frame: Low altitude dojourn at 520m; forst sojourn at 5050m Day 2, 7; second sojourn at 5050m Day 2, 7
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 25 Apr 2018.
- Individual participant dataSharing planned: No
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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.
Marc J Poulin, PhD, DPhil principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing altitude exposure in people with Effect of High Altitude, run by Marc Poulin at 1 site in Canada.
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 2 inclusion and 3 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 25 Apr 2018. 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 Canada. 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?
Sustained attention measured by a visual pychomotor vigilance test (PVT) (time frame: Low altitude dojourn at 520m; forst sojourn at 5050m Day 2, 7; second sojourn at 5050m Day 2, 7). 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 25 Apr 2018.