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CompletedNCT00498563Updated Apr 24, 2015

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

An interventional study of altitude exposure in hypobaric chamber in Altitude, Hypoxia and Environmental Sleep Disorder, sponsored by Oklahoma State University Center for Health Sciences. Completed at 1 site in United States. Open to male participants aged 30 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-04-24.

Sponsored by Oklahoma State University Center for Health Sciences · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
34
Allocation
Randomized
Ages
30 Years to 60 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Altitude
  • Hypoxia
  • Environmental Sleep Disorder

Keywords

  • high altitude
  • sleep
  • altitude illness
  • neurobehavioral manifestations
  • psychomotor performance
  • mood states
03

In context

Sleep Wake Disorders

788 studies on the registry are indexed under Sleep Wake Disorders; 186 are open to participants now.

This study's enrollment of 34 is below the median of 62 across 548 interventional studies indexed under Sleep Wake Disorders.

Browse Sleep Wake Disorders studies →

Lead sponsor

Oklahoma State University Center for Health Sciences is the lead sponsor of 34 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 60 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • healthy
  • age 30 to 60 years

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single
Enrollment
34 participants (actual)

Interventions

  • Procedurealtitude exposure in hypobaric chamber
06

What researchers measure

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)

    Time frame: 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)

    Time frame: 20 hours

07

Study locations

1 site
  • Oklahoma State University Center for Aerospace & Hyperbaric Medicine
    Tulsa, Oklahoma 74132, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 24, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00498563
Lead sponsor
Oklahoma State University Center for Health Sciences
Collaborators
The Boeing Company
First posted
Jul 10, 2007
Start date
Oct 2006
Primary completion
Aug 2007
Completion
Aug 2007
Last update
Apr 24, 2015

Study contacts

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

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.

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