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

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ClinicalTrials.gov Identifier: NCT01130948
Recruitment Status : Completed
First Posted : May 26, 2010
Last Update Posted : May 20, 2014
Sponsor:
Information provided by (Responsible Party):
University of Zurich

Study Description
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Brief Summary:
This study investigates the effect of altitude exposure on sleep, breathing and psychomotor performance in healthy subjects.

Condition or disease Intervention/treatment Phase
Healthy Men Other: altitude exposure Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Official Title: Sleep, Breathing and Psychomotor Performance at Altitude: A Physiologic Study in Healthy Subjects
Study Start Date : May 2010
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010
Arms and Interventions
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Intervention Details:
    Other: altitude exposure
    exposure to 490m, 1700m and 2590m

Outcome Measures
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Primary Outcome Measures :
  1. apnea/hypopnea index [ Time Frame: day 1-4 at altitude ]
  2. Reaction time [ Time Frame: day 1-4 at altitude ]
    psychomotor vigilance test reaction time


Secondary Outcome Measures :
  1. Psychomotor vigilance [ Time Frame: day 1-4 at altitude ]
    performance in the Motor Task Manager test

  2. sleep quality [ Time Frame: day 1-4 at altitude ]
    percent of slow wave sleep, araousal index

  3. arterial applanation tonometry [ Time Frame: day 1-4 at altitude ]
    endothelial function and arterial stiffness


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01130948


Locations
Switzerland
University Hospital of Zurich, Pulmonary Division
Zurich, Switzerland, CH-8091
Sponsors and Collaborators
University of Zurich
Investigators
Principal Investigator: Konrad E Bloch, Prof. MD University Hospital Zurich, Pulmonary Division
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01130948     History of Changes
Other Study ID Numbers: 2010-0054/1
First Posted: May 26, 2010    Key Record Dates
Last Update Posted: May 20, 2014
Last Verified: May 2014

Keywords provided by University of Zurich:
hypoxia
altitude
sleep
sleep apnea
 periodic breathing
vigilance
psychomotor
endothelial function

Additional relevant MeSH terms:
Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes