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The Pre-acclimatization Augmented Extreme Altitude Expedition

NCT05517044 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-12-22

No results posted yet for this study

Summary

The aim of this study is to investigate the effect of pre-acclimatization in a nitrogen tent at home, ventilated with a slightly increased nitrogen percentage, in preparation for an expedition at extreme altitude. Specifically, the current study aims to gather knowledge, whether pre-acclimatization, first, leads to improved capillary function during an expedition to extreme altitude, and second, affects incidence of altitude sickness and the likelihood of reaching the expedition destination without oxygen supplementation.

The project will be carried out in two phases corresponding to two randomized controlled trials in healthy volunteers, who are participating in an expedition at extreme altitudes with or without pre-acclimatization.

Conditions

  • Altitude Hypoxia
  • Perfusion; Complications

Interventions

OTHER

Nitrogen tent preacclimatization to high altitude

The participants assigned to the preacclimatization group spend a minimum of six hours during sleep, throughout the acclimatization period (four weeks preceding the expedition) in a nitrogen concentration tent (Hypoxico OHG, Traunstein, Germany) set to an environmental PO2 corresponding to an altitude of 2500 masl, with a progression to 5500 masl within 28 days in steps of 1000 m every seven days. Respiratory Polygraphy is used to detect periodic breathing, SpO2, and heart rate continuously during sleep and is performed before and after the designated preacclimatization period, and repetitively when increasing normobaric hypoxia in the group with nitrogen concentration tent preacclimatization.

Sponsors & Collaborators

  • Swiss Sportclinic Bern

    collaborator UNKNOWN

  • University of Zurich

    lead OTHER

Principal Investigators

  • Matthias P Hilty, PD Dr. med. · University of Zurich

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-08-04
Primary Completion
2023-11-22
Completion
2024-12-31

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05517044 on ClinicalTrials.gov