Clinical trial NCT01130948: Sleep, Breathing and Psychomotor Performance at Altitude: A Physiologic Study in Healthy Subjects
Official title: Sleep, Breathing and Psychomotor Performance at Altitude: A Physiologic Study in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Men
Keywords: hypoxia
altitude
sleep
sleep apnea
periodic breathing
vigilance
psychomotor
endothelial function
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2010-05-26
Enrollment: 51
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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

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 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)

Primary outcomes:
measure: apnea/hypopnea index
timeFrame: day 1-4 at altitude
measure: Reaction time
timeFrame: day 1-4 at altitude
Secondary outcomes:
measure: Psychomotor vigilance
timeFrame: day 1-4 at altitude
measure: sleep quality
timeFrame: day 1-4 at altitude
measure: arterial applanation tonometry
timeFrame: day 1-4 at altitude
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital of Zurich, Pulmonary Division
Study officials:
affiliation: University Hospital Zurich, Pulmonary Division
name: Konrad E Bloch, Prof. MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Latshang TD, Lo Cascio CM, Stowhas 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.
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.
citation: 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.
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.
citation: Stowhas 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.
citation: 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.