Clinical trial NCT01621061: Sleep Related Breathing Disturbances and High Altitude Pulmonary Hypertension in Kyrgyz Highlanders
Official title: Sleep Apnea and High Altitude Pulmonary Hypertension in Kyrgyz Highlanders
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: High Altitude Pulmonary Hypertension
Sleep Apnea
Keywords: high altitude illness
pulmonary hypertension
sleep apnea
hypoxia
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
First posted: 2012-06-15
Enrollment: 125
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Highlanders with high altitude pumonary hypertension living at an altitude of 2500-4000 m; healthy highlanders living at an altitude of 2500-4000 m; healthy lowlanders living at an altitude of \<1000 m.

Brief summary: High altitude pulmonary hypertension, a form of altitude illness that occurs in long-term residents at altitudes \>2500 m, is characterized by dyspnea, hypoxemia, impaired exercise performance and hypertension in the pulmonary circulation. Whether sleep related breathing disturbances, common causes of nocturnal hypoxemia in lowlanders, are also prevalent in highlanders and promote pulmonary hypertension in highlanders is unknown. Therefore, the current study will investigate whether highlanders with high altitude pulmonary hypertension have a greater prevalence of sleep apnea than healthy highlanders and lowlanders.


Eligibility criteria: 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

Primary outcomes:
measure: Sleep related breathing disturbances
timeFrame: 4 months
Secondary outcomes:
measure: Pulmonary artery pressure
timeFrame: 4 months
measure: Dyspnea
timeFrame: 4 months
measure: Vigilance
timeFrame: 4 months
measure: Exercise performance
timeFrame: 4 months
measure: Pulmonary function
timeFrame: 4 months
measure: Cerebral oxygen saturation
timeFrame: 4 months
measure: Mountain sickness
timeFrame: 4 months
measure: Generic quality of life
timeFrame: 4 months
measure: Disease specific quality of life
timeFrame: 4 months
measure: Subjective sleepiness
timeFrame: 4 months
Other outcomes:
Locations:
city: Bishkek
country: Kyrgyzstan
facility: National Center for Cardiology and Internal Medicine
Study officials:
affiliation: University of Zurich, Switzerland
name: Konrad E Bloch, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
name: Talant Sooronbaev, MD
role: PRINCIPAL_INVESTIGATOR
References: