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

Cheyne-Stokes Respiration Clinical Trial

— PerOxySleep  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01465971
• Other study ID #: ExpedMed#1-2011
• Status: Completed
• Phase: N/A
• First received: October 26, 2011
• Last updated: April 4, 2012
• Start date: May 2011
• Est. completion date: December 2011

Study information

• Verified date: April 2012
• Source: Goethe University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Altitude Sickness
• Cheyne-Stokes Respiration
• Dyssomnias
• Environmental Sleep Disorder
• Parasomnias
• Sleep Disorders

Locations

Country	Name	City	State
Germany	Clinic for Anaesthesia, Intensive Care Medicine and Pain Therapy	Frankfurt	Hesse

Sponsors (1)

Lead Sponsor	Collaborator
Goethe University

Country where clinical trial is conducted

Germany, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tissue oxygenation index	Measured with near infra-red spectroscopy	participants will be followed for the duration of the expedition, an expected 7 days	No
Secondary	Tissue hemoglobin index	measured with near infra-red spectroscopy	participants will be followed for the duration of the expedition, an expected 7 days	No

External Links

•   Working Group for Expeditionmedicine of the Goethe - University Frankfurt/Germany