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

This study has been completed.
Sponsor:
Collaborator:
The Boeing Company
Information provided by:
Oklahoma State University Center for Health Sciences
ClinicalTrials.gov Identifier:
NCT00498563
First received: July 9, 2007
Last updated: July 8, 2008
Last verified: July 2008
  Purpose

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 Intervention
Altitude
Hypoxia
Environmental Sleep Disorder
Procedure: altitude exposure in hypobaric chamber

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind
Primary Purpose: Basic Science
Official Title: Investigation to Determine the Effects of Mild Hypobaric Hypoxia on Sleep and Post-Sleep Neurobehavioral Performance

Resource links provided by NLM:


Further study details as provided by Oklahoma State University Center for Health Sciences:

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) [ Time Frame: 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) [ Time Frame: 20 hours ]

Enrollment: 34
Study Start Date: October 2006
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   30 Years to 60 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00498563

Locations
United States, Oklahoma
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00498563     History of Changes
Other Study ID Numbers: IRB#2006024
Study First Received: July 9, 2007
Last Updated: July 8, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Oklahoma State University Center for Health Sciences:
high altitude
sleep
altitude illness
neurobehavioral manifestations
psychomotor performance
mood states

Additional relevant MeSH terms:
Sleep Disorders
Parasomnias
Anoxia
Dyssomnias
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders
Signs and Symptoms, Respiratory

ClinicalTrials.gov processed this record on September 14, 2014