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Monitoring of the Cerebral Tissue Oxygenation and Perfusion in the Adapting Climber During Sleep in High Altitude (PerOxySleep)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01465971
Recruitment Status : Completed
First Posted : November 6, 2011
Last Update Posted : April 6, 2012
Information provided by (Responsible Party):
Peter Stein, Goethe University

Brief 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. 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.

Condition or disease
Environmental Sleep Disorder Cheyne-Stokes Respiration Altitude Sickness

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).

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Study Type : Observational
Actual Enrollment : 6 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Monitoring of the Cerebral Tissue Oxygenation and Perfusion in the Adapting Climber During the Sleep in High Altitude
Study Start Date : May 2011
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

not acclimatized
no stay in an altitude above 2500 m within the last 3 Months
stay above 2500 m with the last 14 days

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. Tissue hemoglobin index [ Time Frame: participants will be followed for the duration of the expedition, an expected 7 days ]
    measured with near infra-red spectroscopy

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
participants of an expedition to Mount Kilimanjaro

Inclusion Criteria:

  • Age: 18 - 80 years
  • voluntary participation in an expedition to Mount Kilimanjaro

Exclusion Criteria:

  • obstructive or restrictive respiratory disorder
  • hemodynamic relevant cardiac defect
  • sleep disorder

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01465971

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Clinic for Anaesthesia, Intensive Care Medicine and Pain Therapy
Frankfurt, Hesse, Germany, 60318
Sponsors and Collaborators
Goethe University
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Principal Investigator: Peter Stein, Goethe University
Additional Information:
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Responsible Party: Peter Stein, Consultant of the Department for Anesthesiology, Intensive Care Medicine and Pain Therapy of the Goethe-University Frankfurt / Germany - Head of the working group for expedition medicine, Goethe University Identifier: NCT01465971    
Other Study ID Numbers: ExpedMed#1-2011
First Posted: November 6, 2011    Key Record Dates
Last Update Posted: April 6, 2012
Last Verified: April 2012
Keywords provided by Peter Stein, Goethe University:
Additional relevant MeSH terms:
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Cheyne-Stokes Respiration
Altitude Sickness
Sleep Wake Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory