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Sleep and Cerebral Responses to High Altitude (VALLOT 2011)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AdministrateurDRC, University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT01565603
First received: March 26, 2012
Last updated: March 29, 2012
Last verified: March 2012
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by 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

Ages Eligible for Study:   18 Years to 50 Years
Genders 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

No publications provided

Responsible Party: AdministrateurDRC, Principal investigator, University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT01565603     History of Changes
Other Study ID Numbers: RCB 2011-A00071-40
Study First Received: March 26, 2012
Last Updated: March 29, 2012
Health Authority: France: Committee for the Protection of Personnes

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

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

ClinicalTrials.gov processed this record on May 23, 2013