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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01130948
Other study ID # 2010-0054/1
Secondary ID
Status Completed
Phase N/A
First received May 25, 2010
Last updated May 18, 2014
Start date May 2010
Est. completion date October 2010

Study information

Verified date May 2014
Source University of Zurich
Contact n/a
Is FDA regulated No
Health authority Switzerland: Ethikkommission
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor)


Related Conditions & MeSH terms


Intervention

Other:
altitude exposure
exposure to 490m, 1700m and 2590m

Locations

Country Name City State
Switzerland University Hospital of Zurich, Pulmonary Division Zurich

Sponsors (1)

Lead Sponsor Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

References & Publications (5)

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

Outcome

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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