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

Healthy Men Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01130948
• Other study ID #: 2010-0054/1
• 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

• Healthy Men

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