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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Peter Stein, Goethe University
ClinicalTrials.gov Identifier:
NCT01465971
First received: October 26, 2011
Last updated: April 4, 2012
Last verified: April 2012
History of Changes
  Purpose

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
Environmental Sleep Disorder
Cheyne-Stokes Respiration
Altitude Sickness

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

MedlinePlus related topics: Sleep Disorders
U.S. FDA Resources

Further study details as provided by Goethe University:

Primary Outcome Measures:
  • Tissue oxygenation index [ Time Frame: participants will be followed for the duration of the expedition, an expected 7 days ] [ Designated as safety issue: No ]
    Measured with near infra-red spectroscopy


Secondary Outcome Measures:
  • Tissue hemoglobin index [ Time Frame: participants will be followed for the duration of the expedition, an expected 7 days ] [ Designated as safety issue: No ]
    measured with near infra-red spectroscopy


Enrollment: 6
Study Start Date: May 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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).

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

participants of an expedition to Mount Kilimanjaro

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01465971

Locations
Germany
Clinic for Anaesthesia, Intensive Care Medicine and Pain Therapy
Frankfurt, Hesse, Germany, 60318
Sponsors and Collaborators
Goethe University
Investigators
Principal Investigator: Peter Stein, Dr.med. Goethe University
  More Information

Additional Information:
Working Group for Expeditionmedicine of the Goethe - University Frankfurt/Germany  This link exits the ClinicalTrials.gov site

Publications:

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
ClinicalTrials.gov Identifier: NCT01465971     History of Changes
Other Study ID Numbers: ExpedMed#1-2011
Study First Received: October 26, 2011
Last Updated: April 4, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by Goethe University:
high
altitude
acute
mountain
sickness
sleep
 disorder
periodic
breathing
hyperventilation
apnea

Additional relevant MeSH terms:
Altitude Sickness
Cheyne-Stokes Respiration
Sleep Disorders
Parasomnias
Dyssomnias
Respiration Disorders
 Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Nervous System Diseases
Neurologic Manifestations
Mental Disorders

ClinicalTrials.gov processed this record on May 23, 2013