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Sleep and Cerebral Responses to High Altitude (VALLOT 2011)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2012 by AdministrateurDRC, University Hospital, Grenoble.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01565603
First Posted: March 28, 2012
Last Update Posted: March 30, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AdministrateurDRC, University Hospital, Grenoble
  Purpose
Mechanisms underlying high-altitude intolerance as well as exercise performance limitation in hypoxia still remain to be fully understood. Recent data suggest that sleep disturbances on one hand and cerebral perturbations on teh other hand may be key mechanisms. The investigators evaluated 12 healthy subjects at sea level and at 4400 m of altitude for 7 days in order to better describe sleep and cerebral responses. The investigators hypothesized that sleep and cerebral disturbances play a critical role for the developement of acute mountain sickness and for exercise performance limitation during acute high-altitude exposure.

Condition
Acute Mountain Sickness High Altitude Pulmonary Edema High Altitude Cerebral Edema

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Intolerance Mechanisms and Exercise Performance Limitation During a High Altitude Stay: Investigation of Sleep and Cerebral Responses

Resource links provided by NLM:


Further study details as provided by AdministrateurDRC, University Hospital, Grenoble:

Biospecimen Retention:   Samples Without DNA
Venous blood

Enrollment: 12
Study Start Date: July 2011
Estimated Study Completion Date: October 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy young subjects
Criteria

Inclusion Criteria:

  • 18 to 50 yrs old
  • Male

Exclusion Criteria:

  • Respiratory, cardiac, metabolic or neuromuscular diseases
  • History of severe acute mountain sickness
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: AdministrateurDRC, Principal investigator, University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT01565603     History of Changes
Other Study ID Numbers: RCB 2011-A00071-40
First Submitted: March 26, 2012
First Posted: March 28, 2012
Last Update Posted: March 30, 2012
Last Verified: March 2012

Keywords provided by AdministrateurDRC, University Hospital, Grenoble:
Hypoxia
Exercise
Sleep
Brain
Neuromuscular function
Heart

Additional relevant MeSH terms:
Edema
Altitude Sickness
Pulmonary Edema
Brain Edema
Hypertension, Pulmonary
Signs and Symptoms
Respiration Disorders
Respiratory Tract Diseases
Lung Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases


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