Healthy MenNCT01130948
Sleep, Breathing and Psychomotor Performance at Altitude: A Physiologic Study in Healthy Subjects
A study testing altitude exposure in people with Healthy Men, run by University of Zurich at 1 site in Switzerland.
Trial summary
This study investigates the effect of altitude exposure on sleep, breathing and psychomotor performance in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Men
- What is being tested?
- altitude exposure
- How many people
- 51 participants
- Where
- 1 siteSwitzerland
- Study dates
- May 2010to Oct 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy men
- residence at <800m
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital of Zurich, Pulmonary Division
Zurich, CH-8091
About this study
This study investigates the effect of altitude exposure on sleep, breathing and psychomotor performance in healthy subjects.
Read the 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.
- Conditions
- Healthy Men
- Being tested
- altitude exposure
- Keywords
- hypoxia, altitude, sleep, sleep apnea, periodic breathing, vigilance, psychomotor, endothelial function
- Medical subject headings
- Hypoxia, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
altitude exposureOther
exposure to 490m, 1700m and 2590m
What is being measured
The primary outcome is the main question the study is designed to answer.
apnea/hypopnea index
Measured: day 1-4 at altitude
Reaction time
psychomotor vigilance test reaction time
Measured: day 1-4 at altitude
Secondary outcomes (3)
Psychomotor vigilance
performance in the Motor Task Manager test
Measured: day 1-4 at altitude
sleep quality
percent of slow wave sleep, araousal index
Measured: day 1-4 at altitude
arterial applanation tonometry
endothelial function and arterial stiffness
Measured: day 1-4 at altitude
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2010 (estimated)
- Study startMay 2010
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Healthy MenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Konrad E Bloch, Prof. MD, Principal investigator, University Hospital Zurich, Pulmonary Division
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01130948
- Sponsor's protocol ID
- 2010-0054/1
- Status last verified
- May 2014
- First submitted
- 25 May 2010
- Last updated
- 20 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24293773Stadelmann 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.
PubMed 24552365Ayers 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.
PubMed 24514947Stadelmann 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.
PubMed 24167552Stowhas 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.
PubMed 23936377Stadelmann 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.
PubMed 25723529
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep, Breathing and Psychomotor Performance at Altitude: A Physiologic Study in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01130948
- Acronym / sponsor ID
- 2010-0054/1
- Conditions
- Healthy Men
- Keywords
- hypoxia, altitude, sleep, sleep apnea, periodic breathing, vigilance, psychomotor, endothelial function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 26 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- healthy men
- residence at <800m
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| altitude exposureexposure to 490m, 1700m and 2590m | Other | – |
Primary outcome
apnea/hypopnea index
Time frame: day 1-4 at altitude
Reaction time
Time frame: day 1-4 at altitude
psychomotor vigilance test reaction time
3 secondary outcomes
Psychomotor vigilance
Time frame: day 1-4 at altitude
sleep quality
Time frame: day 1-4 at altitude
arterial applanation tonometry
Time frame: day 1-4 at altitude
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2014.
- Background: PubMed 24293773Latshang 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.
- Background: PubMed 24552365Stadelmann 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.
- Background: PubMed 24514947Ayers 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.
- Background: PubMed 24167552Stadelmann 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.
- Background: PubMed 23936377Stowhas 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.
- Derived from this study: PubMed 25723529Stadelmann 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.
Related trials for Healthy Men
Active, not recruitingPhase 1
A Study to Compare How 2 Different Formulations of Survodutide Are Taken up in the Body When Given by Injection in Healthy Men and Women With and Without Overweight or Obesity
Healthy, Obesity
RecruitingPhase 1
A Study in Healthy Men to Test How Well Different Doses of BI 3776528 Are Tolerated
Healthy
Not yet recruitingPhase 4
Study to Evaluate the Effect of Zoliflodacin on Testicular Function in Healthy Adult Men
Testicular Abnominalies
Not yet recruiting
Effects of Tart Cherry and Aronia Extract Supplementation on Selected Physiological Parameters in Endurance-Trained Men
Cardiovascular Physiology
Active, not recruitingPhase 1
Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of BGM1812 Injection Following Single and Multiple Subcutaneous Administration in Normal to Overweight or Obese But Otherwise Healthy Men and Women
Healhty, Overweight or Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Konrad E Bloch, Prof. MD principal investigator
University Hospital Zurich, Pulmonary Division
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing altitude exposure in people with Healthy Men, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
apnea/hypopnea index (time frame: day 1-4 at altitude). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01130948, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2014.