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

NCT ID: NCT00498563

Last Updated: 2015-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2007-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Altitude Hypoxia Environmental Sleep Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Interventions

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altitude exposure in hypobaric chamber

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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The Boeing Company

INDUSTRY

Sponsor Role collaborator

Oklahoma State University Center for Health Sciences

OTHER

Sponsor Role lead

Principal Investigators

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J. Michael Muhm, M.D., M.P.H.

Role: PRINCIPAL_INVESTIGATOR

The Boeing Company

Paul B Rock, DO, PhD

Role: PRINCIPAL_INVESTIGATOR

Oklahoma State University Center for Aerospace & Hyperbaric Medicine

Locations

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Oklahoma State University Center for Aerospace & Hyperbaric Medicine

Tulsa, Oklahoma, United States

Site Status

Countries

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United States

Other Identifiers

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IRB#2006024

Identifier Type: -

Identifier Source: org_study_id

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