NCT02731456

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 3, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 7, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
Last Updated

April 25, 2018

Status Verified

April 1, 2018

Enrollment Period

1.8 years

First QC Date

April 3, 2016

Last Update Submit

April 23, 2018

Conditions

Effect of High Altitude

Keywords

high altitudecognitionsleep

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    Low altitude dojourn at 520m; forst sojourn at 5050m Day 2, 7; second sojourn at 5050m Day 2, 7

Study Arms (1)

Altitude exposure

EXPERIMENTAL

Acute high altitude exposure followed by 8 day acclimatization and re-exposure for 8 days after 6 days at low altitude.

Other: altitude exposure

Interventions

altitude exposureOTHER

altitude exposure

Altitude exposure

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • born, raised and currently living \<1300m
  • No overnight stays at altitudes \>1500m 4 weeks before the study

You may not qualify if:

  • previous altitude intolerance \<3000m
  • pregnancy
  • health impairment, which requires regular treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Calgary

Calgary, Alberta, T2N 4N1, Canada

Location

MeSH Terms

Conditions

Altitude Sickness

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Study Officials

  • Marc J Poulin, PhD, DPhil

    University of Calgary

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 3, 2016

First Posted

April 7, 2016

Study Start

March 1, 2016

Primary Completion

December 31, 2017

Study Completion

December 31, 2017

Last Updated

April 25, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)