Environmental Sleep DisorderPerOxySleepNCT01465971
Monitoring of the Cerebral Tissue Oxygenation and Perfusion in the Adapting Climber During Sleep in High Altitude
An observational study of Environmental Sleep Disorder and Cheyne-Stokes Respiration, run by Goethe University at 1 site in Germany.
Trial summary
One of the major challenges in adapting to high altitudes is that with increasing altitude sleeping quality declines rapidly. Thus, the night sleep can only provide limited to none regeneration. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Environmental Sleep Disorder, Cheyne-Stokes Respiration, Altitude Sickness
- How many people
- 6 participants
- Where
- 1 siteGermany
- Study dates
- May 2011to Dec 2011
- Phase
- Observational
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: participants of an expedition to Mount Kilimanjaro
Who may be able to join
- Age: 18 - 80 years
- voluntary participation in an expedition to Mount Kilimanjaro
Who cannot join
- obstructive or restrictive respiratory disorder
- hemodynamic relevant cardiac defect
- sleep disorder
Trial locations and contacts
1 site in 1 country.
Germany1 site
Clinic for Anaesthesia, Intensive Care Medicine and Pain Therapy
Frankfurt am Main, Hesse, 60318
About this study
Official title: Monitoring of the Cerebral Tissue Oxygenation and Perfusion in the Adapting Climber During the Sleep in High Altitude
One of the major challenges in adapting to high altitudes is that with increasing altitude sleeping quality declines rapidly. Thus, the night sleep can only provide limited to none regeneration. It usually takes a prolonged stay at a constant altitude to adapt sufficiently to the altitude and to have a refreshing night sleep. 1975 Reit et. al showed in their EEG-recordings that the sleep architecture (the regular succession of the particular sleep phases) is disturbed by repeating arousals which occur due to an irregularity in the breathing rhythm.
The purpose of this study is to create a better understanding of the underlying mechanisms that lead to failed acclimatization and AMS, due to sleep disturbance.
Read the detailed description
Under sea level conditions humans breath between 10 and 12 times per minute. The breathing cycle in high altitude is accelerated. If the conscious breathing control vanishes during sleep a periodic breathing with alternating episodes of hyperventilation and apnea is the result. This circumstance causes repetitive arousals that do not allow a normal sleep pattern. The associated adverse effects are fatigue, slow or failed acclimatization, weakening of the immune system, lack of motivation and the disability to make rational decisions.
Sleep deprivation is a common reason for the abortion of a trip, accidents and severe forms of Acute Mountain Sickness (AMS).
- Keywords
- high, altitude, acute, mountain, sickness, sleep, disorder, periodic, breathing, hyperventilation, apnea
- Medical subject headings
- Dyssomnias, Cheyne-Stokes Respiration, Altitude Sickness, Disease, Respiratory Aspiration, Hyperventilation, Apnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| not acclimatized | no stay in an altitude above 2500 m within the last 3 Months | |
| acclimatized | stay above 2500 m with the last 14 days |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tissue oxygenation index
Measured with near infra-red spectroscopy
Measured: participants will be followed for the duration of the expedition, an expected 7 days
Secondary outcomes (1)
Tissue hemoglobin index
measured with near infra-red spectroscopy
Measured: participants will be followed for the duration of the expedition, an expected 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2011 (estimated)
- Study startMay 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Environmental Sleep DisorderStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Goethe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Stein, Goethe University
- Investigators
- Peter Stein, Dr.med., Principal investigator, Goethe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01465971
- Sponsor's protocol ID
- ExpedMed#1-2011
- Acronym
- PerOxySleep
- Status last verified
- Apr 2012
- First submitted
- 26 Oct 2011
- Last updated
- 6 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Jackson SJ, Varley J, Sellers C, Josephs K, Codrington L, Duke G, Njelekela MA, Drummond G, Sutherland AI, Thompson AA, Baillie JK. Incidence and predictors of acute mountain sickness among trekkers on Mount Kilimanjaro. High Alt Med Biol. 2010 Fall;11(3):217-22. doi: 10.1089/ham.2010.1003.
PubMed 20919888Szymczak RK, Sitek EJ, Slawek JW, Basinski A, Sieminski M, Wieczorek D. Subjective sleep quality alterations at high altitude. Wilderness Environ Med. 2009 Winter;20(4):305-10. doi: 10.1580/1080-6032-020.004.0305.
PubMed 20030436
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring of the Cerebral Tissue Oxygenation and Perfusion in the Adapting Climber During the Sleep in High Altitude
- ClinicalTrials.gov ID
- NCT01465971
- Acronym / sponsor ID
- PerOxySleep / ExpedMed#1-2011
- Keywords
- high, altitude, acute, mountain, sickness, sleep, disorder, periodic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Goethe UniversityUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 7 Nov 2011 (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.
One of the major challenges in adapting to high altitudes is that with increasing altitude sleeping quality declines rapidly. Thus, the night sleep can only provide limited to none regeneration. It usually takes a prolonged stay at a constant altitude to adapt sufficiently to the altitude and to have a refreshing night sleep. 1975 Reit et. al showed in their EEG-recordings that the sleep architecture (the regular succession of the particular sleep phases) is disturbed by repeating arousals which occur due to an irregularity in the breathing rhythm.
The purpose of this study is to create a better understanding of the underlying mechanisms that lead to failed acclimatization and AMS, due to sleep disturbance.
Detailed description
Under sea level conditions humans breath between 10 and 12 times per minute. The breathing cycle in high altitude is accelerated. If the conscious breathing control vanishes during sleep a periodic breathing with alternating episodes of hyperventilation and apnea is the result. This circumstance causes repetitive arousals that do not allow a normal sleep pattern. The associated adverse effects are fatigue, slow or failed acclimatization, weakening of the immune system, lack of motivation and the disability to make rational decisions.
Sleep deprivation is a common reason for the abortion of a trip, accidents and severe forms of Acute Mountain Sickness (AMS).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| not acclimatized | – | –no stay in an altitude above 2500 m within the last 3 Months |
| acclimatized | – | –stay above 2500 m with the last 14 days |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- participants of an expedition to Mount Kilimanjaro
Key inclusion criteria (2 listed)
- Age: 18 - 80 years
- voluntary participation in an expedition to Mount Kilimanjaro
Key exclusion criteria (3 listed)
- obstructive or restrictive respiratory disorder
- hemodynamic relevant cardiac defect
- sleep disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Tissue oxygenation index
Time frame: participants will be followed for the duration of the expedition, an expected 7 days
Measured with near infra-red spectroscopy
1 secondary outcome
Tissue hemoglobin index
Time frame: participants will be followed for the duration of the expedition, an expected 7 days
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 6 Apr 2012.
- Background: PubMed 20919888Jackson SJ, Varley J, Sellers C, Josephs K, Codrington L, Duke G, Njelekela MA, Drummond G, Sutherland AI, Thompson AA, Baillie JK. Incidence and predictors of acute mountain sickness among trekkers on Mount Kilimanjaro. High Alt Med Biol. 2010 Fall;11(3):217-22. doi: 10.1089/ham.2010.1003.
- Background: PubMed 20030436Szymczak RK, Sitek EJ, Slawek JW, Basinski A, Sieminski M, Wieczorek D. Subjective sleep quality alterations at high altitude. Wilderness Environ Med. 2009 Winter;20(4):305-10. doi: 10.1580/1080-6032-020.004.0305.
- Working Group for Expeditionmedicine of the Goethe - University Frankfurt/GermanyLink provided by the sponsor.
Related trials for Environmental Sleep Disorder
Not yet recruiting
SmartEnLite for Nursing Home Residents With Dementia
Alzheimer's Disease and Related Dementias, Alzheimer Disease and Related Dementias
Not yet recruiting
Study of Bedroom Environment Sleep Intervention at Home for Older Adults Living Alone With Memory Concerns
Subjective Cognitive Decline (SCD), Mild Cognitive Impairment (MCI)
Not yet recruiting
Effect of a Nurse-Led Environmental Stressor Reduction Package on Perceived Stress and Sleep Quality in Intensive Care Unit Patients
Sleep Disturbance
Active, not recruiting
Novel Strategies for Reducing Heart Disease Risk Disparities
Cardiovascular Diseases
RecruitingPhase 4
Comparing Acupuncture With Medication to Reduce Depression, Anxiety and Comorbid Sleep Disorders in China
Anxiety Depression, Sleep
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.
Peter Stein, Dr.med. principal investigator
Goethe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Environmental Sleep Disorder and Cheyne-Stokes Respiration, run by Goethe University at 1 site in Germany.
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 2 inclusion and 3 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 6 Apr 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 Germany. 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?
Tissue oxygenation index (time frame: participants will be followed for the duration of the expedition, an expected 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01465971, which also lists 2 linked publications.
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 6 Apr 2012.