Sleep, Breathing and Psychomotor Performance at Altitude: A Physiologic Study in Healthy Subjects - Full Text View

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:

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 (Adult, Senior)
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:

Latshang TD, Lo Cascio CM, Stöwhas AC, Grimm M, Stadelmann K, Tesler N, Achermann P, Huber R, Kohler M, Bloch KE. Are nocturnal breathing, sleep, and cognitive performance impaired at moderate altitude (1,630-2,590 m)? Sleep. 2013 Dec 1;36(12):1969-76. doi: 10.5665/sleep.3242.

Stadelmann K, Latshang TD, Tarokh L, Lo Cascio CM, Tesler N, Stoewhas AC, Kohler M, Bloch KE, Huber R, Achermann P. Sleep respiratory disturbances and arousals at moderate altitude have overlapping electroencephalogram spectral signatures. J Sleep Res. 2014 Aug;23(4):463-8. doi: 10.1111/jsr.12131. Epub 2014 Feb 19.

Ayers L, Stoewhas AC, Ferry B, Latshang TD, Lo Cascio CM, Sadler R, Stadelmann K, Tesler N, Huber R, Achermann P, Bloch KE, Kohler M. Circulating levels of cell-derived microparticles are reduced by mild hypobaric hypoxia: data from a randomised controlled trial. Eur J Appl Physiol. 2014 May;114(5):1067-73. doi: 10.1007/s00421-014-2837-6. Epub 2014 Feb 11.

Stadelmann K, Latshang TD, Lo Cascio CM, Tesler N, Stoewhas AC, Kohler M, Bloch KE, Huber R, Achermann P. Quantitative changes in the sleep EEG at moderate altitude (1630 m and 2590 m). PLoS One. 2013 Oct 22;8(10):e76945. doi: 10.1371/journal.pone.0076945. eCollection 2013.

Stöwhas AC, Latshang TD, Lo Cascio CM, Lautwein S, Stadelmann K, Tesler N, Ayers L, Berneis K, Gerber PA, Huber R, Achermann P, Bloch KE, Kohler M. Effects of acute exposure to moderate altitude on vascular function, metabolism and systemic inflammation. PLoS One. 2013 Aug 1;8(8):e70081. doi: 10.1371/journal.pone.0070081. Print 2013.

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

Stadelmann K, Latshang TD, Lo Cascio CM, Clark RA, Huber R, Kohler M, Achermann P, Bloch KE. Impaired postural control in healthy men at moderate altitude (1630 m and 2590 m): data from a randomized trial. PLoS One. 2015 Feb 27;10(2):e0116695. doi: 10.1371/journal.pone.0116695. eCollection 2015.


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

Additional relevant MeSH terms:


Respiratory Aspiration Respiration Disorders Respiratory Tract Diseases Pathologic Processes

ClinicalTrials.gov processed this record on September 30, 2016