- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01565603
Sleep and Cerebral Responses to High Altitude (VALLOT 2011)
March 29, 2012 updated by: AdministrateurDRC, University Hospital, Grenoble
Intolerance Mechanisms and Exercise Performance Limitation During a High Altitude Stay: Investigation of Sleep and Cerebral Responses
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.
Study Overview
Status
Unknown
Study Type
Observational
Enrollment (Actual)
12
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Sampling Method
Non-Probability Sample
Study Population
Healthy young subjects
Description
Inclusion Criteria:
- 18 to 50 yrs old
- Male
Exclusion Criteria:
- Respiratory, cardiac, metabolic or neuromuscular diseases
- History of severe acute mountain sickness
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2011
Primary Completion (Actual)
October 1, 2011
Study Completion (Anticipated)
October 1, 2012
Study Registration Dates
First Submitted
March 26, 2012
First Submitted That Met QC Criteria
March 26, 2012
First Posted (Estimate)
March 28, 2012
Study Record Updates
Last Update Posted (Estimate)
March 30, 2012
Last Update Submitted That Met QC Criteria
March 29, 2012
Last Verified
March 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RCB 2011-A00071-40
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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