Training in Hypoxia to Prevent Acute Mountain Sickness | NCT00886912

Studies
Training in Hypoxia to Prevent Acute Mountain Sickness

NCT00886912

Sponsor

Heidelberg University

Status

Unknown status

Last Update Posted

Jun 25, 2010Estimated

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Acute Mountain Sickness
Healthy

Interventions

hypoxia
normoxia

Countries

Germany

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

Apr 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2008

Primary Completion Date

Aug 2008Actual

Completion Date

Oct 2009Estimated

First Submitted Date

Apr 21, 2009

First Submission Date that Met QC Criteria

Apr 22, 2009

First Posted Date

Apr 23, 2009Estimated

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

Jun 24, 2010

Last Update Posted Date

Jun 25, 2010Estimated

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

Some studies suggest that high-altitude related illnesses - like acute mountain sickness - could be prevented by acclimatisation, reached at low altitude using training in simulated altitude. The purpose of this study is to determine whether training in hypoxia is suitable to prevent acute mountain sickness.

Detailed Description

In a three week-period, healthy probands undergo 3 times a week a bicycle ergometer training in simulated altitude followed by 1 week passive exposure at simulated low altitude. 5 days after last exposure, a field study starts performing a rapid ascent to the Capanna Regina Margherita (4559m). Acute mountain sickness is assessed by established scoring systems.

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

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hypoxia	Active Comparator	training in simulated altitude	Other: hypoxia
Normoxia	Placebo Comparator	training under normoxic conditions	Other: normoxia

Interventions

Name	Type	Description	Arm Group Labels	Other Names
hypoxia	Other	training in simulated altitude in a hypoxic chamber (normobaric hypoxia)	Hypoxia

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of acute mountain sickness		after 20 hours at 4559m

Secondary Outcomes

Measure	Description	Time Frame
Severity of acute mountain sickness		after 20 hours at 4559m

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

healthy
non-smoker
endurance training min. 2x/week

Exclusion Criteria:

any diseases
previous exposure to altitudes higher than 2000m (last 6 weeks)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Kai Schommer, MD	Contact	+496221568256		kai.schommer@med.uni-heidelberg.de
Peter Baertsch, MD	Contact	+496221568101		peter_baertsch@med.uni-heidelberg.de

Overall Officials

Name	Affiliation	Role
Kai Schommer, MD	Departement of Sports Medicine, University of Heidelberg	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Departement of Sports Medicine, University of Heidelberg	Recruiting	Heidelberg		69120	Germany

Condition Browse Module

MeSH Terms

ID	Term
D000532	Altitude Sickness

Ancestor Terms

ID	Term
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided