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

April 22, 2015 updated by: Oklahoma State University Center for Health Sciences

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
7 hours; 4 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
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
20 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oklahoma State University Center for Health Sciences

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (Actual)

August 1, 2007

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

July 9, 2007

First Submitted That Met QC Criteria

July 9, 2007

First Posted (Estimate)

July 10, 2007

Study Record Updates

Last Update Posted (Estimate)

April 24, 2015

Last Update Submitted That Met QC Criteria

April 22, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB#2006024

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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