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

April 4, 2012 updated by: Peter Stein, Goethe University

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.

Study Overview

Status

Completed

Conditions

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

Enrollment (Actual)

6

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Hesse
      • Frankfurt, Hesse, Germany, 60318
        • Clinic for Anaesthesia, Intensive Care Medicine and Pain Therapy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

participants of an expedition to Mount Kilimanjaro

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
participants will be followed for the duration of the expedition, an expected 7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
participants will be followed for the duration of the expedition, an expected 7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Goethe University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

October 26, 2011

First Submitted That Met QC Criteria

November 2, 2011

First Posted (Estimate)

November 6, 2011

Study Record Updates

Last Update Posted (Estimate)

April 6, 2012

Last Update Submitted That Met QC Criteria

April 4, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ExpedMed#1-2011

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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