NCT01245491

Brief Summary

The purpose of this study is:

  1. 1.To study the effect of whole-body vibration on partial pressure of oxygen in arterial blood (PaO2), under hypobaric hypoxic conditions.
  2. 2.To study the effects of whole-body vibration and hypobaric hypoxia on visual contrast sensitivity.
  3. 3.To se if there is an increase in cytokines and other biomarkers under different hypobaric hypoxic conditions Our main hypothesis is that whole-body vibration may cause PaO2 to drop to a lower level, at a given altitude; than would be the case if there were no vibration present.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2010

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

October 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 19, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 22, 2010

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

January 14, 2011

Status Verified

January 1, 2011

Enrollment Period

2 months

First QC Date

November 19, 2010

Last Update Submit

January 13, 2011

Conditions

Hypoxia

Outcome Measures

Primary Outcomes (2)

  • PaO2

    Assessed at six different altitudes

    14 minutes

  • PaO2

    Assessed at six dfferent altitudes

    35 minutes

Secondary Outcomes (2)

  • Ventilation

    14 minutes

  • Ventilation

    35 minutes

Interventions

VibrationOTHER

Whole-body vibration, 17 Hz, 1.1ms-2

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

  • Stay at altitude over 2000 m last two weeks prior to study-start.
  • Severe head injury
  • Cardiovascular disease
  • lung disease
  • Decompression sickness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hypoxia

Interventions

Vibration

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mechanical PhenomenaPhysical Phenomena

Study Officials

  • Tor A Hansen, Msc.

    Institute of Aviation Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

November 19, 2010

First Posted

November 22, 2010

Study Start

October 1, 2010

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

January 14, 2011

Record last verified: 2011-01