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Completed

NCT Number: NCT00498563

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

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.

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Key information

Conditions

Altitude Altitude Sickness Dyssomnias Environmental Sleep Disorder Hypoxia Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Sleep Wake Disorders

Age range

30 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Oklahoma State University Center for Aerospace & Hyperbaric Medicine

Tulsa, Oklahoma, 74132, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

altitude exposure in hypobaric chamber

Procedure

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

Sponsors and collaborators

Lead sponsor

Oklahoma State University Center for Health Sciences

Other

Collaborators

  • The Boeing Company

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Jul 10, 2007
Registry last updated
Apr 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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