The Effects of Vibration on Hypoxia | NCT01245491

Studies
The Effects of Vibration on Hypoxia

NCT01245491

Sponsor

Institute of Aviation Medicine, Oslo, Norway

Status

Completed

Last Update Posted

Jan 14, 2011Estimated

Enrollment

13Actual

Phase

Not Applicable

Conditions

Hypoxia

Interventions

Vibration

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2010

Primary Completion Date

Dec 2010Actual

Completion Date

Dec 2010Actual

First Submitted Date

Nov 19, 2010

First Submission Date that Met QC Criteria

Nov 19, 2010

First Posted Date

Nov 22, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 13, 2011

Last Update Posted Date

Jan 14, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

13Actual

Name	Type	Description	Arm Group Labels	Other Names
Vibration	Other	Whole-body vibration, 17 Hz, 1.1ms-2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
PaO2	Assessed at six different altitudes	14 minutes
PaO2	Assessed at six dfferent altitudes	35 minutes

Secondary Outcomes

Measure	Description	Time Frame
Ventilation	Assessed at six different altitudes, over a period of three minutes.	14 minutes
Ventilation	Assessed over a periode of three minutes, at six different altitudes.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tor A Hansen, Msc.	Institute of Aviation Medicine	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000860	Hypoxia

Ancestor Terms

ID	Term
D012818	Signs and Symptoms, Respiratory
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014732	Vibration

Ancestor Terms

ID	Term
D055595	Mechanical Phenomena
D055585	Physical Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided