NCT02829255

Brief Summary

Prospective interventional trial in lowlanders evaluating the effect of acute exposure, acclimatization and re-exposure to high altitude on cerebral autoregulation

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2016

Shorter than P25 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

First Submitted

Initial submission to the registry

April 1, 2016

Completed
8 days until next milestone

Study Start

First participant enrolled

April 9, 2016

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 4, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 4, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 12, 2016

Completed
Last Updated

January 17, 2019

Status Verified

January 1, 2019

Enrollment Period

25 days

First QC Date

April 1, 2016

Last Update Submit

January 15, 2019

Conditions

Effect of High Altitude

Keywords

High altitudeCerebral autoregulationTransfer function analysis

Outcome Measures

Primary Outcomes (1)

  • Coherence between middle cerebral artery blood flow velocity and systemic blood pressure as measure of cerebral autoregulation.

    Change in magnitude of the coefficient of coherence between blood flow velocity in the middle cerebral artery measured by transcranial ultrasound Doppler and systemic blood pressure at day 2 (5050 m) vs. day 1 (520 m) of the first cycle

    day 1; day 2 first cycle

Secondary Outcomes (4)

  • Coherence between middle cerebral artery blood flow velocity and systemic blood pressure as measure of cerebral autoregulation.

    day 1; day 7 first cycle

  • Coherence between middle cerebral artery blood flow velocity and systemic blood pressure as measure of cerebral autoregulation.

    day 2; day 7 second cycle

  • Coherence between middle cerebral artery blood flow velocity and systemic blood pressure as measure of cerebral autoregulation.

    day 2 first cycle; day 2 second cycle

  • Coherence between middle cerebral artery blood flow velocity and systemic blood pressure as measure of cerebral autoregulation.

    day 7 first cycle; day 7 second cycle

Study Arms (1)

Altitude exposure

EXPERIMENTAL

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

Other: altitude exposure

Interventions

altitude exposureOTHER

altitude exposure

Altitude exposure

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Born, raised and currently living \<800m
  • No overnight stay at altitudes \>1500 m 4 weeks before the study

You may not qualify if:

  • Previous altitude intolerance to altitude \<3000 m
  • Pregnancy
  • Health impairment, which requires regular treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Zurich

Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Altitude Sickness

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Study Officials

  • Konrad E Bloch, MD

    University of Zurich

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

April 1, 2016

First Posted

July 12, 2016

Study Start

April 9, 2016

Primary Completion

May 4, 2016

Study Completion

May 4, 2016

Last Updated

January 17, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)