Sleep, Breathing and Psychomotor Performance at Altitude: A Physiologic Study in Healthy Subjects

May 18, 2014 updated by: University of Zurich
This study investigates the effect of altitude exposure on sleep, breathing and psychomotor performance in healthy subjects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Sleep is essential for well being and performance. Sleep disturbances by recurrent apnea and hypoxia in patients with obstructive sleep apnea syndrome impair quality of life, cognitive and cardiovascular functions. Similar consequences occur in healthy subjects exposed to hypoxia at altitude due to periodic breathing with recurrent central apnea. This project will investigate effects of altitude on sleep, breathing, psychomotor performance and on the cardiovascular system in healthy subjects and patients with sleep apnea. The results will help to better understand mechanisms of sleep disturbances and psychomotor impairment induced by hypoxia and to prevent adverse effects of altitude exposure.

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Zurich, Switzerland, CH-8091
        • University Hospital of Zurich, Pulmonary Division

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • healthy men
  • residence at <800m

Exclusion Criteria:

  • any active disease requiring treatment
  • requirement for regular use of medication
  • smoking, regular intake of alcohol or drugs
  • body mass index <18 or >30 kg/m2
  • previous intolerance of moderate altitude (<3000m)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
apnea/hypopnea index
Time Frame: day 1-4 at altitude
day 1-4 at altitude
Reaction time
Time Frame: day 1-4 at altitude
psychomotor vigilance test reaction time
day 1-4 at altitude

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Psychomotor vigilance
Time Frame: day 1-4 at altitude
performance in the Motor Task Manager test
day 1-4 at altitude
sleep quality
Time Frame: day 1-4 at altitude
percent of slow wave sleep, araousal index
day 1-4 at altitude
arterial applanation tonometry
Time Frame: day 1-4 at altitude
endothelial function and arterial stiffness
day 1-4 at altitude

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Konrad E Bloch, Prof. MD, University Hospital Zurich, Pulmonary Division

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

May 25, 2010

First Submitted That Met QC Criteria

May 25, 2010

First Posted (Estimate)

May 26, 2010

Study Record Updates

Last Update Posted (Estimate)

May 20, 2014

Last Update Submitted That Met QC Criteria

May 18, 2014

Last Verified

May 1, 2014

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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