Effects of Mild Hypobaric Hypoxia on Sleep and Post-sleep Performance
Investigation to Determine the Effects of Mild Hypobaric Hypoxia on Sleep and Post-Sleep Neurobehavioral Performance
1 other identifier
interventional
34
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2006
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2006
CompletedFirst Submitted
Initial submission to the registry
July 9, 2007
CompletedFirst Posted
Study publicly available on registry
July 10, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2007
CompletedApril 24, 2015
April 1, 2015
10 months
July 9, 2007
April 22, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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
Interventions
Eligibility Criteria
You may qualify if:
- healthy
- age 30 to 60 years
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Oklahoma State University Center for Aerospace & Hyperbaric Medicine
Tulsa, Oklahoma, 74132, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 9, 2007
First Posted
July 10, 2007
Study Start
October 1, 2006
Primary Completion
August 1, 2007
Study Completion
August 1, 2007
Last Updated
April 24, 2015
Record last verified: 2015-04