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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 University Hospital, Grenoble.
Recruitment status was:  Active, not recruiting
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
  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 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   (Adult)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on December 08, 2016