NCT01130948

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

May 25, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 26, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

May 20, 2014

Status Verified

May 1, 2014

Enrollment Period

5 months

First QC Date

May 25, 2010

Last Update Submit

May 18, 2014

Conditions

Keywords

hypoxiaaltitudesleepsleep apneaperiodic breathingvigilancepsychomotorendothelial function

Outcome Measures

Primary Outcomes (2)

  • apnea/hypopnea index

    day 1-4 at altitude

  • Reaction time

    psychomotor vigilance test reaction time

    day 1-4 at altitude

Secondary Outcomes (3)

  • Psychomotor vigilance

    day 1-4 at altitude

  • sleep quality

    day 1-4 at altitude

  • arterial applanation tonometry

    day 1-4 at altitude

Interventions

exposure to 490m, 1700m and 2590m

Eligibility Criteria

Age18 Years - 70 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy men
  • residence at \<800m

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Zurich, Pulmonary Division

Zurich, CH-8091, Switzerland

Location

Related Publications (6)

  • 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.

    PMID: 24293773BACKGROUND
  • 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.

    PMID: 24552365BACKGROUND
  • 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.

    PMID: 24514947BACKGROUND
  • 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.

    PMID: 24167552BACKGROUND
  • 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.

    PMID: 23936377BACKGROUND
  • 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.

MeSH Terms

Conditions

HypoxiaSleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Konrad E Bloch, Prof. MD

    University Hospital Zurich, Pulmonary Division

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2010

First Posted

May 26, 2010

Study Start

May 1, 2010

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

May 20, 2014

Record last verified: 2014-05

Locations