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

Primary Purpose

Altitude, Hypoxia, Environmental Sleep Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
altitude exposure in hypobaric chamber
Sponsored by
Oklahoma State University Center for Health Sciences
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional basic science trial for Altitude focused on measuring high altitude, sleep, altitude illness, neurobehavioral manifestations, psychomotor performance, mood states

Eligibility Criteria

30 Years - 60 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Oklahoma State University Center for Aerospace & Hyperbaric Medicine

Outcomes

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)

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)

Full Information

First Posted
July 9, 2007
Last Updated
April 22, 2015
Sponsor
Oklahoma State University Center for Health Sciences
Collaborators
The Boeing Company
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1. Study Identification

Unique Protocol Identification Number
NCT00498563
Brief Title
Effects of Mild Hypobaric Hypoxia on Sleep and Post-sleep Performance
Official Title
Investigation to Determine the Effects of Mild Hypobaric Hypoxia on Sleep and Post-Sleep Neurobehavioral Performance
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
August 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Oklahoma State University Center for Health Sciences
Collaborators
The Boeing Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Altitude, Hypoxia, Environmental Sleep Disorder
Keywords
high altitude, sleep, altitude illness, neurobehavioral manifestations, psychomotor performance, mood states

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Single
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
altitude exposure in hypobaric chamber
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
J. Michael Muhm, M.D., M.P.H.
Organizational Affiliation
The Boeing Company
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Paul B Rock, DO, PhD
Organizational Affiliation
Oklahoma State University Center for Aerospace & Hyperbaric Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oklahoma State University Center for Aerospace & Hyperbaric Medicine
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74132
Country
United States

12. IPD Sharing Statement

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

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