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

NCT ID: NCT01465971

Last Updated: 2012-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

6 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-05-31

Study Completion Date

2011-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Environmental Sleep Disorder Cheyne-Stokes Respiration Altitude Sickness

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

not acclimatized

no stay in an altitude above 2500 m within the last 3 Months

No interventions assigned to this group

acclimatized

stay above 2500 m with the last 14 days

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Goethe University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Peter Stein

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

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Peter Stein, Dr.med.

Role: PRINCIPAL_INVESTIGATOR

Goethe University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Clinic for Anaesthesia, Intensive Care Medicine and Pain Therapy

Frankfurt am Main, Hesse, Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 20919888 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20030436 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

http://www.expeditionsmedizin.de

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

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ExpedMed#1-2011

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Sleep Measurement Study
NCT04288557 COMPLETED
Vital Signs Reduction Study
NCT06865781 ACTIVE_NOT_RECRUITING NA