Effects of Mild Hypobaric Hypoxia on Oxygen Saturation During Sleep
Primary Purpose
Sleep-related Respiratory Disturbance
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Reduced barometric pressure
Sea level equivalent barometric pressure
Reduced barometric pressure
Sponsored by
About this trial
This is an interventional basic science trial for Sleep-related Respiratory Disturbance focused on measuring environmental, hypobaric hypoxia, sleep, respiratory-disturbance, neurobehavioral performance, Effect of altitude on sleep-related respiratory disturbance
Eligibility Criteria
Inclusion Criteria:
- Male
- Between 30 and 60 years of age.
- Healthy, able to pass FAA Class III examination
- Body mass index less than 30
- Height less than 75 inches
- Ability to read and speak English
Exclusion Criteria:
- Prolonged residence above 5000 feet
- Recent travel to altitudes above 5000 feet
- Use of drugs or medications that affect sleep
- History of mood or psychiatric disorders that affect sleep.
- History of medical conditions that increase risk of adverse effects of hypoxia.
- Apnea hypopnea index greater than 15/hr at ground level.
Sites / Locations
- Environmental Physiology Unit, School of Kinesiology, Simon Fraser University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
1
2
3
Arm Description
Barometric pressure equivalent to sea level (760 mm Hg).
Barometric pressure equivalent to 6000 feet (609 mm Hg)
Barometric pressure equivalent to 8000 feet (565 mm Hg).
Outcomes
Primary Outcome Measures
SpO2
Respiratory Disturbance
Sleep architecture
Secondary Outcome Measures
Heart rate variability
Full Information
NCT ID
NCT00659009
First Posted
April 14, 2008
Last Updated
August 14, 2012
Sponsor
The Boeing Company
Collaborators
Simon Fraser University, Massey University
1. Study Identification
Unique Protocol Identification Number
NCT00659009
Brief Title
Effects of Mild Hypobaric Hypoxia on Oxygen Saturation During Sleep
Official Title
The Effects of Mild Hypobaric Hypoxia on Oxygen Saturation During Sleep: An Investigation of the Physiologic Mechanisms and Significance
Study Type
Interventional
2. Study Status
Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Boeing Company
Collaborators
Simon Fraser University, Massey University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Ascent to altitude lowers oxygen saturation. In addition, sleep lowers oxygen saturation at any altitude. In a prior study, we observed that sleep at 8000 feet resulted in pronounced reduction in oxygen saturation, but did not result in reduced post sleep neurobehavioral performance or impaired sleep quality or quantity. We plan to do a more sophisticated physiological evaluation of the respiratory mechanisms responsible for the reduced oxygen saturation and determine if there are any adverse consequences to this level of intermittent hypoxia. We anticipate that central respiratory apnea is the physiologic mechanism, and that there will not be persistent changes in autonomic nervous activity measured by heart rate variability.
Detailed Description
This study has 6 primary objectives/hypotheses:
Replicate findings of earlier study in which no effects of altitude were observed on post sleep neurobehavioral performance, sleep quantity or quality.
Determine if sleep at 6000 feet has effects similar to sleep at 8000 feet.
Identify if central or obstructive apnea is responsible for the reduction in oxygen saturation observed during sleep at 8000 feet.
Determine if respiratory abnormalities observed at 6000 feet are similar but less severe than at 8000 feet.
Determine if there are individual differences in respiratory physiology at sea level that enable prediction of pronounced respiratory disturbances during sleep at altitude.
Determine if changes in autonomic nervous activity, measured by heart rate variability, occur, and if so, do they persist for 8 hours.
Twenty healthy males between 30 and 60 years of age whose baseline apnea-hypopnea index is less than 15/hour will be recruited from the general population surrounding Burnaby, British Columbia, Canada. Women are excluded because of the changes in sleep structure associated with the menstrual cycle.
Participants will be involved in the blinded crossover study for a 14 day period during which time they will monitor their sleep by actigraphy and sleep diaries, will spend 2 nights an altitude chamber at Simon Fraser University at ambient barometric pressure to become adapted to sleeping in that environment, then spend 3 study nights, each followed by 2 rest nights, sleeping at barometric pressures equivalent to sea level, 6000 feet, and 8000 feet. The order of exposures will be randomly balanced.
Pre study physiologic measures will include hypoxic ventilatory response, hypercapnic ventilatory response, and during one of the adaptation nights, apnea hypoxia index. Study sessions will consist of a 4 hour presleep period, a 6 hour sleep period, and a 1 hour post sleep period at the study barometric pressure. During the study sessions, heart rate, SpO2, polysomnographic measures, nasal air flow rates, and chest motion will be monitored and recorded. Psychomotor Vigilance Task response time will be measured before and after the sleep period. Heart rate will be recorded by ambulatory recording equipment for 8 hours following return to ambient barometric pressure conditions. This will be analyzed to determine if changes in heart rate variability are persistent.
Outcomes of primary interest will include total sleep time, duration of sleep stages, oxygen saturation, heart rate and heart rate variability, respiratory rates, air flow, and chest motion to assess if central or obstructive apnea is temporally related to reductions in oxygen saturation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep-related Respiratory Disturbance
Keywords
environmental, hypobaric hypoxia, sleep, respiratory-disturbance, neurobehavioral performance, Effect of altitude on sleep-related respiratory disturbance
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Barometric pressure equivalent to sea level (760 mm Hg).
Arm Title
2
Arm Type
Experimental
Arm Description
Barometric pressure equivalent to 6000 feet (609 mm Hg)
Arm Title
3
Arm Type
Experimental
Arm Description
Barometric pressure equivalent to 8000 feet (565 mm Hg).
Intervention Type
Other
Intervention Name(s)
Reduced barometric pressure
Intervention Description
Sleep in reduced barometric pressure environment.
Intervention Type
Other
Intervention Name(s)
Sea level equivalent barometric pressure
Intervention Description
Sleep in barometric pressure equivalent to sea level.
Intervention Type
Other
Intervention Name(s)
Reduced barometric pressure
Intervention Description
Sleep in reduced barometric pressure environment.
Primary Outcome Measure Information:
Title
SpO2
Time Frame
Continuous during sleep
Title
Respiratory Disturbance
Time Frame
Continuous during sleep
Title
Sleep architecture
Time Frame
Continuous during sleep
Secondary Outcome Measure Information:
Title
Heart rate variability
Time Frame
Continuous during sleep and 8 hr following exposure
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:
Male
Between 30 and 60 years of age.
Healthy, able to pass FAA Class III examination
Body mass index less than 30
Height less than 75 inches
Ability to read and speak English
Exclusion Criteria:
Prolonged residence above 5000 feet
Recent travel to altitudes above 5000 feet
Use of drugs or medications that affect sleep
History of mood or psychiatric disorders that affect sleep.
History of medical conditions that increase risk of adverse effects of hypoxia.
Apnea hypopnea index greater than 15/hr at ground level.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James M Muhm, MD, MPH
Organizational Affiliation
The Boeing Company
Official's Role
Principal Investigator
Facility Information:
Facility Name
Environmental Physiology Unit, School of Kinesiology, Simon Fraser University
City
Burnaby
State/Province
British Columbia
ZIP/Postal Code
V5A 1S6
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Effects of Mild Hypobaric Hypoxia on Oxygen Saturation During Sleep
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