Clinical trial NCT01465971: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Environmental Sleep Disorder
Cheyne-Stokes Respiration
Altitude Sickness
Keywords: high
altitude
acute
mountain
sickness
sleep
disorder
periodic
breathing
hyperventilation
apnea
Lead sponsor: Goethe University
Sponsor class: OTHER
First posted: 2011-11-06
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: participants of an expedition to Mount Kilimanjaro

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).

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

Primary outcomes:
measure: Tissue oxygenation index
timeFrame: participants will be followed for the duration of the expedition, an expected 7 days
Secondary outcomes:
measure: Tissue hemoglobin index
timeFrame: participants will be followed for the duration of the expedition, an expected 7 days
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: Clinic for Anaesthesia, Intensive Care Medicine and Pain Therapy
state: Hesse
Study officials:
affiliation: Goethe University
name: Peter Stein, Dr.med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jackson SJ, Varley J, Sellers C, Josephs K, Codrington L, Duke G, Njelekela MA, Drummond G, Sutherland AI, Thompson AA, Baillie JK. Incidence and predictors of acute mountain sickness among trekkers on Mount Kilimanjaro. High Alt Med Biol. 2010 Fall;11(3):217-22. doi: 10.1089/ham.2010.1003.
citation: Szymczak RK, Sitek EJ, Slawek JW, Basinski A, Sieminski M, Wieczorek D. Subjective sleep quality alterations at high altitude. Wilderness Environ Med. 2009 Winter;20(4):305-10. doi: 10.1580/1080-6032-020.004.0305.