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

• ClinicalTrials.gov Identifier: NCT01130948
• Recruitment Status: Completed
• First Posted: May 26, 2010
• Last Update Posted: May 20, 2014
• Sponsor: University of Zurich
• Information provided by (Responsible Party): University of Zurich

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Healthy Men	Other: altitude exposure	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 51 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Outcomes Assessor)
• Official Title: Sleep, Breathing and Psychomotor Performance at Altitude: A Physiologic Study in Healthy Subjects
• Study Start Date: May 2010
• Actual Primary Completion Date: October 2010
• Actual Study Completion Date: October 2010

Arms and Interventions

Intervention Details:

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

Outcome Measures

Primary Outcome Measures :

1. apnea/hypopnea index [ Time Frame: day 1-4 at altitude ]
2. Reaction time [ Time Frame: day 1-4 at altitude ]
   psychomotor vigilance test reaction time

Secondary Outcome Measures :

1. Psychomotor vigilance [ Time Frame: day 1-4 at altitude ]
   performance in the Motor Task Manager test
2. sleep quality [ Time Frame: day 1-4 at altitude ]
   percent of slow wave sleep, araousal index
3. arterial applanation tonometry [ Time Frame: day 1-4 at altitude ]
   endothelial function and arterial stiffness

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes 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

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
• Other Study ID Numbers: 2010-0054/1
• First Posted: May 26, 2010
• Last Update Posted: May 20, 2014
• Last Verified: May 2014

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