Sleep and Cerebral Responses to High Altitude

Acute Mountain Sickness Clinical Trial

— VALLOT 2011  

Official title:

Intolerance Mechanisms and Exercise Performance Limitation During a High Altitude Stay: Investigation of Sleep and Cerebral Responses

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01565603
• Other study ID #: RCB 2011-A00071-40
• Status: Active, not recruiting
• Phase: N/A
• First received: March 26, 2012
• Last updated: March 29, 2012
• Start date: July 2011
• Est. completion date: October 2012

Study information

• Verified date: March 2012
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of Personnes
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 12
• Est. completion date: October 2012
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• 18 to 50 yrs old

• Male

Exclusion Criteria:

• Respiratory, cardiac, metabolic or neuromuscular diseases

• History of severe acute mountain sickness

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Acute Mountain Sickness
• Altitude Sickness
• Brain Edema
• Edema
• High Altitude Cerebral Edema
• High Altitude Pulmonary Edema
• Hypertension, Pulmonary
• Pulmonary Edema

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble