- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01245491
The Effects of Vibration on Hypoxia
January 13, 2011 updated by: Institute of Aviation Medicine, Oslo, Norway
The purpose of this study is:
- To study the effect of whole-body vibration on partial pressure of oxygen in arterial blood (PaO2), under hypobaric hypoxic conditions.
- To study the effects of whole-body vibration and hypobaric hypoxia on visual contrast sensitivity.
- 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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
13
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
Exclusion Criteria:
- Stay at altitude over 2000 m last two weeks prior to study-start.
- Severe head injury
- Cardiovascular disease
- lung disease
- Decompression sickness
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Interventional Model: Crossover Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PaO2
Time Frame: 14 minutes
|
Assessed at six different altitudes
|
14 minutes
|
PaO2
Time Frame: 35 minutes
|
Assessed at six dfferent altitudes
|
35 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ventilation
Time Frame: 14 minutes
|
Assessed at six different altitudes, over a period of three minutes.
|
14 minutes
|
Ventilation
Time Frame: 35 minutes
|
Assessed over a periode of three minutes, at six different altitudes.
|
35 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Tor A Hansen, Msc., Institute of Aviation Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2010
Primary Completion (Actual)
December 1, 2010
Study Completion (Actual)
December 1, 2010
Study Registration Dates
First Submitted
November 19, 2010
First Submitted That Met QC Criteria
November 19, 2010
First Posted (Estimate)
November 22, 2010
Study Record Updates
Last Update Posted (Estimate)
January 14, 2011
Last Update Submitted That Met QC Criteria
January 13, 2011
Last Verified
January 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REK-2010/2021b
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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