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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01130948
First received: May 25, 2010
Last updated: May 18, 2014
Last verified: May 2014
  Purpose

This study investigates the effect of altitude exposure on sleep, breathing and psychomotor performance in healthy subjects.


Condition Intervention
Healthy Men
Other: altitude exposure

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: Sleep, Breathing and Psychomotor Performance at Altitude: A Physiologic Study in Healthy Subjects

Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • apnea/hypopnea index [ Time Frame: day 1-4 at altitude ] [ Designated as safety issue: No ]
  • Reaction time [ Time Frame: day 1-4 at altitude ] [ Designated as safety issue: No ]
    psychomotor vigilance test reaction time


Secondary Outcome Measures:
  • Psychomotor vigilance [ Time Frame: day 1-4 at altitude ] [ Designated as safety issue: No ]
    performance in the Motor Task Manager test

  • sleep quality [ Time Frame: day 1-4 at altitude ] [ Designated as safety issue: No ]
    percent of slow wave sleep, araousal index

  • arterial applanation tonometry [ Time Frame: day 1-4 at altitude ] [ Designated as safety issue: No ]
    endothelial function and arterial stiffness


Enrollment: 51
Study Start Date: May 2010
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: altitude exposure
    exposure to 490m, 1700m and 2590m
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Publications:

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01130948     History of Changes
Other Study ID Numbers: 2010-0054/1
Study First Received: May 25, 2010
Last Updated: May 18, 2014
Health Authority: Switzerland: Ethikkommission

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

ClinicalTrials.gov processed this record on November 24, 2014