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

NCT01465971 | Completed

• 1 other identifier: ExpedMed#1-2011
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Environmental Sleep Disorder; Cheyne-Stokes Respiration; Altitude Sickness

Keywords

high; altitude; acute; mountain; sickness; sleep; disorder; periodic; breathing; hyperventilation; apnea

Outcome Measures

Primary Outcomes (1)

• Tissue oxygenation index

  Measured with near infra-red spectroscopy

  participants will be followed for the duration of the expedition, an expected 7 days

Secondary Outcomes (1)

• Tissue hemoglobin index

  participants will be followed for the duration of the expedition, an expected 7 days

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

participants of an expedition to Mount Kilimanjaro

You may qualify if:

• Age: 18 - 80 years
• voluntary participation in an expedition to Mount Kilimanjaro

You may not qualify if:

• obstructive or restrictive respiratory disorder
• hemodynamic relevant cardiac defect
• sleep disorder

Sponsors & Collaborators

• Goethe University: lead

Study Sites (1)

Clinic for Anaesthesia, Intensive Care Medicine and Pain Therapy

Frankfurt am Main, Hesse, 60318, Germany

Location

Related 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.

  PMID: 20919888 BACKGROUND

• 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.

  PMID: 20030436 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Dyssomnias; Cheyne-Stokes Respiration; Altitude Sickness; Disease; Respiratory Aspiration; Hyperventilation; Apnea

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Peter Stein, Dr.med.

  Goethe University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: 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

Study Record Dates

• First Submitted: October 26, 2011
• First Posted: November 7, 2011
• Study Start: May 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: April 6, 2012

Record last verified: 2012-04

Locations

DE (1)