Effects of Mild Hypobaric Hypoxia on Sleep and Post-sleep Performance

Sponsor

Oklahoma State University Center for Health Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT00498563

Collaborator

The Boeing Company (Industry)

Enrollment

Location

Duration (Months)

3.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Hypobaric hypoxia (decreased oxygen supply to body tissues due to low atmospheric pressure) caused by exposure to high altitude disrupts sleep. Sleep deprivation is associated with degraded post-sleep performance of neurobehavioral tasks. The lowest altitude at which sleep and/or post-sleep performance are affected is not known. The study hypothesis is that sleep and/or post-sleep performance of neurobehavioral tasks will occur due to hypobaric hypoxia at altitudes of 8,000 or less.

Condition or Disease	Intervention/Treatment	Phase
Altitude Hypoxia Environmental Sleep Disorder	Procedure: altitude exposure in hypobaric chamber	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

34 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single

Primary Purpose:

Basic Science

Official Title:

Investigation to Determine the Effects of Mild Hypobaric Hypoxia on Sleep and Post-Sleep Neurobehavioral Performance

Study Start Date :

Oct 1, 2006

Actual Primary Completion Date :

Aug 1, 2007

Actual Study Completion Date :

Aug 1, 2007

Outcome Measures

Primary Outcome Measures

Quality and quantity of sleep measured by actigraphy and polysomnography Neurobehavioral performance measured by Psychomotor Vigilance Test (PVT) and Automated Neurophysiologic Assessment Metrics Battery (ANAM) [7 hours; 4 hours]

Secondary Outcome Measures

Mood State measured by Profile of Mood States (POMS) Symptoms of altitude illness measured by Environmental Symptoms Questionnaire (ESQ IV) and Lake Louise Symptom Scores (LLS) [20 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 60 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

healthy
age 30 to 60 years

Exclusion Criteria:

sleep disorders or abnormal sleep patterns
mood or psychiatric disorders including claustrophobia
altitude exposure above 5,000 ft in the previous 2 months
born or raised at terrestrial altitude 5,000 ft or greater
conditions that would disqualify for FAA Medical Certificate
acute medical conditions

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Oklahoma State University Center for Aerospace & Hyperbaric Medicine	Tulsa	Oklahoma	United States	74132

Sponsors and Collaborators

Oklahoma State University Center for Health Sciences
The Boeing Company

Investigators

Principal Investigator: J. Michael Muhm, M.D., M.P.H., The Boeing Company
Principal Investigator: Paul B Rock, DO, PhD, Oklahoma State University Center for Aerospace & Hyperbaric Medicine