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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01621061 |
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Date of registration:
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13/06/2012 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Sleep Related Breathing Disturbances and High Altitude Pulmonary Hypertension in Kyrgyz Highlanders
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Scientific title:
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Sleep Apnea and High Altitude Pulmonary Hypertension in Kyrgyz Highlanders |
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Date of first enrolment:
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June 2012 |
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Target sample size:
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125 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01621061 |
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Study type:
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Observational |
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Study design:
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Observational Model: Case Control, Time Perspective: Prospective
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Phase:
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N/A
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Countries of recruitment
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Kyrgyzstan
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Contacts
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Name:
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Konrad E Bloch, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Zurich, Switzerland |
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Name:
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Talant Sooronbaev, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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National Center for Cardiology and Internal Medicine, Bishkek, Kyrgyzstan |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- high altitude pulmonary hypertension confirmed by clinical presentation and systolic
pulmonary artery pressure >50 mmHg measured by echocardiography at altitude of
residence.
- healthy subjects (high altitude controls)
- Both genders
- Age >16 y
- Kyrgyz ethnicity
- born, raised and currently living at >2500 m
- healthy subjects currently living at <1000 m (low altitude controls)
Exclusion criteria:
- Pulmonary hypertension from other causes, in particular from left ventricular failure
as judged clinically and by echocardiography
- excessive erythrocytosis
- other coexistent disorders that may interfere with the cardio-respiratory system and
sleep
- regular use of medication that affects control of breathing
- heavy smoking
Age minimum:
16 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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High Altitude Pulmonary Hypertension
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Sleep Apnea
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Primary Outcome(s)
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Sleep related breathing disturbances
[Time Frame: 4 months]
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Secondary Outcome(s)
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Cerebral oxygen saturation
[Time Frame: 4 months]
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Mountain sickness
[Time Frame: 4 months]
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Pulmonary artery pressure
[Time Frame: 4 months]
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Pulmonary function
[Time Frame: 4 months]
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Exercise performance
[Time Frame: 4 months]
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Dyspnea
[Time Frame: 4 months]
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Generic quality of life
[Time Frame: 4 months]
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Disease specific quality of life
[Time Frame: 4 months]
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Subjective sleepiness
[Time Frame: 4 months]
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Vigilance
[Time Frame: 4 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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