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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00498563
Other study ID # IRB#2006024
Secondary ID
Status Completed
Phase N/A
First received July 9, 2007
Last updated April 22, 2015
Start date October 2006
Est. completion date August 2007

Study information

Verified date April 2015
Source Oklahoma State University Center for Health Sciences
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 34
Est. completion date August 2007
Est. primary completion date August 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 30 Years to 60 Years
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind, Primary Purpose: Basic Science


Intervention

Procedure:
altitude exposure in hypobaric chamber


Locations

Country Name City State
United States Oklahoma State University Center for Aerospace & Hyperbaric Medicine Tulsa Oklahoma

Sponsors (2)

Lead Sponsor Collaborator
Oklahoma State University Center for Health Sciences The Boeing Company

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
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