Sleep-related Respiratory DisturbanceNCT00659009
Effects of Mild Hypobaric Hypoxia on Oxygen Saturation During Sleep
A study testing Reduced barometric pressure and Sea level equivalent barometric pressure in people with Sleep-related Respiratory Disturbance, run by The Boeing Company at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sleep-related Respiratory Disturbance
- What is being tested?
- Reduced barometric pressure and Sea level equivalent barometric pressure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteCanada
- Study dates
- May 2008to Mar 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Environmental Physiology Unit, School of Kinesiology, Simon Fraser University
Burnaby, British Columbia, V5A 1S6
About this study
Official title: The Effects of Mild Hypobaric Hypoxia on Oxygen Saturation During Sleep: An Investigation of the Physiologic Mechanisms and Significance
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.
Read the 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.
- Conditions
- Sleep-related Respiratory Disturbance
- Being tested
- Reduced barometric pressure, Sea level equivalent barometric pressure
- Keywords
- environmental, hypobaric hypoxia, sleep, respiratory-disturbance, neurobehavioral performance, Effect of altitude on sleep-related respiratory disturbance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reduced barometric pressureOther
Sleep in reduced barometric pressure environment.
Sea level equivalent barometric pressureOther
Sleep in barometric pressure equivalent to sea level.
Reduced barometric pressureOther
Sleep in reduced barometric pressure environment.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Barometric pressure equivalent to sea level (760 mm Hg). Receives: Other: Sea level equivalent barometric pressure |
| 2 | Experimental | Barometric pressure equivalent to 6000 feet (609 mm Hg) Receives: Other: Reduced barometric pressure |
| 3 | Experimental | Barometric pressure equivalent to 8000 feet (565 mm Hg). Receives: Other: Reduced barometric pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
SpO2
Measured: Continuous during sleep
Respiratory Disturbance
Measured: Continuous during sleep
Sleep architecture
Measured: Continuous during sleep
Secondary outcomes (1)
Heart rate variability
Measured: Continuous during sleep and 8 hr following exposure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2008 (estimated)
- Study startMay 2008
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep-related Respiratory DisturbanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Boeing Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Simon Fraser University, Massey University
- Responsible party
- Sponsor
- Investigators
- James M Muhm, MD, MPH, Principal investigator, The Boeing Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00659009
- Sponsor's protocol ID
- Boeing-003
- Status last verified
- Feb 2010
- First submitted
- 14 Apr 2008
- Last updated
- 15 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Mild Hypobaric Hypoxia on Oxygen Saturation During Sleep: An Investigation of the Physiologic Mechanisms and Significance
- ClinicalTrials.gov ID
- NCT00659009
- Acronym / sponsor ID
- Boeing-003
- Conditions
- Sleep-related Respiratory Disturbance
- Keywords
- environmental, hypobaric hypoxia, sleep, respiratory-disturbance, neurobehavioral performance, Effect of altitude on sleep-related respiratory disturbance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- The Boeing CompanyIndustry (pharma, biotech, devices)
- Collaborators
- Simon Fraser University, Massey University
- Study start
- May 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 16 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Other: Sea level equivalent barometric pressureBarometric pressure equivalent to sea level (760 mm Hg). |
| 2 | Experimental | Other: Reduced barometric pressureBarometric pressure equivalent to 6000 feet (609 mm Hg) |
| 3 | Experimental | Other: Reduced barometric pressureBarometric pressure equivalent to 8000 feet (565 mm Hg). |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reduced barometric pressureSleep in reduced barometric pressure environment. | Other | 2 |
| Sea level equivalent barometric pressureSleep in barometric pressure equivalent to sea level. | Other | 1 |
| Reduced barometric pressureSleep in reduced barometric pressure environment. | Other | 3 |
Primary outcome
SpO2
Time frame: Continuous during sleep
Respiratory Disturbance
Time frame: Continuous during sleep
Sleep architecture
Time frame: Continuous during sleep
1 secondary outcome
Heart rate variability
Time frame: Continuous during sleep and 8 hr following exposure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James M Muhm, MD, MPH principal investigator
The Boeing Company
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reduced barometric pressure and Sea level equivalent barometric pressure in people with Sleep-related Respiratory Disturbance, run by The Boeing Company at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SpO2 (time frame: Continuous during sleep). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2012.