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

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Brief Title

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

Official Title

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

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.
    

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 Type

Observational


Primary Outcome

Tissue oxygenation index

Secondary Outcome

 Tissue hemoglobin index

Condition

Environmental Sleep Disorder


Study Arms / Comparison Groups

 not acclimatized
Description:  no stay in an altitude above 2500 m within the last 3 Months

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

6

Start Date

May 2011

Completion Date

December 2011

Primary Completion Date

December 2011

Eligibility Criteria

        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
      

Gender

All

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Peter Stein, Dr.med., , 

Location Countries

Germany

Location Countries

Germany

Administrative Informations


NCT ID

NCT01465971

Organization ID

ExpedMed#1-2011


Responsible Party

Principal Investigator

Study Sponsor

Goethe University


Study Sponsor

Peter Stein, Dr.med., Principal Investigator, Goethe University


Verification Date

April 2012