NCT03303118

Brief Summary

The investigators will investigate the effect of hypobaria and hypoxia on physiological responses such as: oxygen saturation, heart rate, cerebral blood flow, cerebral oxygenation, brain's activity and concentration performance.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2017

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 2, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 5, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

November 16, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 5, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 5, 2018

Completed
Last Updated

August 18, 2021

Status Verified

August 1, 2021

Enrollment Period

4 months

First QC Date

October 2, 2017

Last Update Submit

August 17, 2021

Conditions

Cerebral Hypoxia

Keywords

HypoxiaBrainCerebral vaso-reactivityEEGConcentration performanceCerebral oxygenationCerebral blood-flowHeart rate variability

Outcome Measures

Primary Outcomes (1)

  • Concentration performance

    Performance of concentration at different altitude levels.

    4 minutes per test

Secondary Outcomes (1)

  • EEG micro-states

    5 minutes per record

Other Outcomes (1)

  • Cerebral vaso-reactivity

    8 Minutes per test

Study Arms (1)

Left

OTHER

No product administration will be done in this study.

Other: Hypoxia

Interventions

HypoxiaOTHER

No drug or product will be used in this study. No medication will be give to the participants. No arm will be used for product administration.

Left

Eligibility Criteria

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

You may qualify if:

  • No history of flight sickness
  • No relevant medical diseases
  • Age 18 - 40 years
  • Written consent acceptance

You may not qualify if:

  • Known pathologies
  • Relevant medical disorders
  • Drug addiction
  • Anemia or poor health
  • People who have already had problems with elevation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mathias Aebi

Dübendorf, Canton of Zurich, 8600, Switzerland

Location

Related Publications (1)

  • Aebi MR, Bourdillon N, Kunz A, Bron D, Millet GP. Specific effect of hypobaria on cerebrovascular hypercapnic responses in hypoxia. Physiol Rep. 2020 Feb;8(4):e14372. doi: 10.14814/phy2.14372.

    PMID: 32097541DERIVED

MeSH Terms

Conditions

Hypoxia, BrainHypoxia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Single-Blind study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. med Denis Bron

Study Record Dates

First Submitted

October 2, 2017

First Posted

October 5, 2017

Study Start

November 16, 2017

Primary Completion

March 5, 2018

Study Completion

March 5, 2018

Last Updated

August 18, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Results will be shared in scientific publications by the end of this year and in 2018.

Locations

CH(1)