Effects of High AltitudeNCT02451020
Acclimatization of Healthy Subjects During a Stay at 3200 m
A study testing Altitude exposure in people with Effects of High Altitude, run by University of Zurich at 1 site in Kyrgyzstan.
Trial summary
The study evaluates respiratory acclimatization in healthy lowlanders staying for 3 weeks at 3200 m. Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Effects of High Altitude
- What is being tested?
- Altitude exposure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteKyrgyzstan
- Study dates
- 8 Jun 2015to 9 Aug 2015
- 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 20 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Perfect health
- Born, raised and currently living at low altitude (<800m)
- Informed consent.
Who cannot join
- Any acute or chronic disease
- heavy smoking (>20 cigarettes per day).
Trial locations and contacts
1 site in 1 country.
Kyrgyzstan1 site
National Center of Cardiology and Internal Medicine
Bishkek, 720040
About this study
The study evaluates respiratory acclimatization in healthy lowlanders staying for 3 weeks at 3200 m.
Read the detailed description
This study evaluates the effect of 3 weeks altitude acclimatization on sleep related breathing disturbances in healthy subjects staying at 3200 m. Participants living in Bishkek, Kyrgyzstan (700 m), will be transferred by car within 4 h to the Tuja Ashu high altitude clinic (3200 m). Outcomes will be assessed repeatedly during the stay at 3200 m.
- Conditions
- Effects of High Altitude
- Being tested
- Altitude exposure
- Keywords
- healthy volunteers, acclimatization, sleep, hypoxia
- Medical subject headings
- Altitude Sickness, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Altitude exposureOther
Participants will stay for 3 weeks at an altitude of 3200 m
| Study group | Role | What they receive |
|---|---|---|
| Altitude exposure | Experimental | Stay at 3200 m for 3 weeks Receives: Other: Altitude exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean nocturnal oxygen saturation measured by pulse oximetry
Difference in mean nocturnal oxygen saturation between night 1 and night 7
Measured: night 7 at 3200 m
Secondary outcomes (3)
Mean nocturnal oxygen saturation measured by pulse oximetry
Difference in mean nocturnal oxygen saturation between night 1 at 3200 and night 1 at 700 m
Measured: night 1 at 3200 m
Mean nocturnal oxygen saturation measured by pulse oximetry
Difference in mean nocturnal oxygen saturation between night 21 and night 1 at 3200 m
Measured: night 21 at 3200 m
Mean nocturnal oxygen saturation measured by pulse oximetry
Mean nocturnal oxygen saturation during night 1 at 700 m
Measured: night 1 at 700 m (low altitude baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2015 (estimated)
- Study start8 Jun 2015
- Primary completion9 Aug 2015
- Study completion9 Aug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effects of High AltitudeStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- 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
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
- Responsible party
- Sponsor
- Investigators
- Konrad E Bloch, MD, Study chair, University Hospital, ZürichTalant M Sooronbaev, MD, Study director, National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02451020
- Sponsor's protocol ID
- EK15-2015_V2
- Status last verified
- Oct 2018
- First submitted
- 18 May 2015
- Last updated
- 30 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acclimatization of Healthy Subjects During a Stay at 3200 m
- ClinicalTrials.gov ID
- NCT02451020
- Acronym / sponsor ID
- EK15-2015_V2
- Conditions
- Effects of High Altitude
- Keywords
- healthy volunteers, acclimatization, sleep, hypoxia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
- Study start
- 8 Jun 2015 (actual)
- Primary completion
- 9 Aug 2015 (actual)
- Study completion
- 9 Aug 2015 (actual)
- First posted
- 21 May 2015 (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.
The study evaluates respiratory acclimatization in healthy lowlanders staying for 3 weeks at 3200 m.
Detailed description
This study evaluates the effect of 3 weeks altitude acclimatization on sleep related breathing disturbances in healthy subjects staying at 3200 m. Participants living in Bishkek, Kyrgyzstan (700 m), will be transferred by car within 4 h to the Tuja Ashu high altitude clinic (3200 m). Outcomes will be assessed repeatedly during the stay at 3200 m.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Altitude exposure | Experimental | Other: Altitude exposureStay at 3200 m for 3 weeks |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Perfect health
- Born, raised and currently living at low altitude (<800m)
- Informed consent.
Key exclusion criteria (2 listed)
- Any acute or chronic disease
- heavy smoking (>20 cigarettes per day).
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 exposureParticipants will stay for 3 weeks at an altitude of 3200 m | Other | Altitude exposure |
Primary outcome
Mean nocturnal oxygen saturation measured by pulse oximetry
Time frame: night 7 at 3200 m
Difference in mean nocturnal oxygen saturation between night 1 and night 7
3 secondary outcomes
Mean nocturnal oxygen saturation measured by pulse oximetry
Time frame: night 1 at 3200 m
Mean nocturnal oxygen saturation measured by pulse oximetry
Time frame: night 21 at 3200 m
Mean nocturnal oxygen saturation measured by pulse oximetry
Time frame: night 1 at 700 m (low altitude baseline)
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 30 Oct 2018.
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Optimization of Two-Indicator Screening Protocol for Neonatal Congenital Heart Disease at High Altitude
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Assessment of Total Pulmonary Resistance sPAP/CO Between High Altitude HA vs. Sea Level LA in Healthy Individuals H
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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, MD study chair
University Hospital, Zürich
Talant M Sooronbaev, MD study director
National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan
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 Effects of High Altitude, run by University of Zurich at 1 site in Kyrgyzstan.
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 3 inclusion and 2 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 30 Oct 2018. 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 Kyrgyzstan. 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?
Mean nocturnal oxygen saturation measured by pulse oximetry (time frame: night 7 at 3200 m). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Oct 2018.