Healthy Men Clinical Trial
Official title:
Sleep, Breathing and Psychomotor Performance at Altitude: A Physiologic Study in Healthy Subjects
Verified date | May 2014 |
Source | University of Zurich |
Contact | n/a |
Is FDA regulated | No |
Health authority | Switzerland: Ethikkommission |
Study type | Interventional |
This study investigates the effect of altitude exposure on sleep, breathing and psychomotor performance in healthy subjects.
Status | Completed |
Enrollment | 51 |
Est. completion date | October 2010 |
Est. primary completion date | October 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 70 Years |
Eligibility |
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) |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor)
Country | Name | City | State |
---|---|---|---|
Switzerland | University Hospital of Zurich, Pulmonary Division | Zurich |
Lead Sponsor | Collaborator |
---|---|
University of Zurich |
Switzerland,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | apnea/hypopnea index | day 1-4 at altitude | No | |
Primary | Reaction time | psychomotor vigilance test reaction time | day 1-4 at altitude | No |
Secondary | Psychomotor vigilance | performance in the Motor Task Manager test | day 1-4 at altitude | No |
Secondary | sleep quality | percent of slow wave sleep, araousal index | day 1-4 at altitude | No |
Secondary | arterial applanation tonometry | endothelial function and arterial stiffness | day 1-4 at altitude | No |
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