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Completed

NCT Number: NCT01465971

Monitoring of the Cerebral Tissue Oxygenation and Perfusion in the Adapting Climber During 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.

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Key information

Conditions

Environmental Sleep Disorder Altitude Sickness Apnea Cheyne-Stokes Respiration Disease Dyssomnias Hyperventilation Mental Disorders Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Sleep Wake Disorders

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinic for Anaesthesia, Intensive Care Medicine and Pain Therapy

Frankfurt am Main, Hesse, 60318, Germany

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Goethe University

Other

Registry information

Official study title

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

Acronym: PerOxySleep

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Nov 7, 2011
Registry last updated
Apr 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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