Sleep Related Breathing Disturbances and High Altitude Pulmonary Hypertension in Kyrgyz Highlanders

Sponsor

University of Zurich (Other)

Overall Status

Completed

CT.gov ID

NCT01621061

Collaborator

National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov (Other)

125

Enrollment

Location

Duration (Months)

6.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
High Altitude Pulmonary Hypertension Sleep Apnea

Study Design

Study Type:

Observational

Actual Enrollment :

125 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Sleep Apnea and High Altitude Pulmonary Hypertension in Kyrgyz Highlanders

Study Start Date :

Jun 1, 2012

Actual Primary Completion Date :

Dec 1, 2013

Actual Study Completion Date :

Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
High altitude pulmonary hypertension Highlanders with high altitude pulmonary hypertension
High altitude control Healthy highlanders
Low altitude control Healthy lowlanders

Outcome Measures

Primary Outcome Measures

Sleep related breathing disturbances [4 months]
Nocturnal oxygen saturation and apnea/hypopnea index

Secondary Outcome Measures

Pulmonary artery pressure [4 months]
Echocardiography
Dyspnea [4 months]
NYHA functional class
Vigilance [4 months]
Psychomotor vigilance
Exercise performance [4 months]
6 min walk test
Pulmonary function [4 months]
Spirometry
Cerebral oxygen saturation [4 months]
Near-infrared spectroscopy
Mountain sickness [4 months]
Quinghai chronic mountain sickness score
Generic quality of life [4 months]
SF-36 quality of life questionnaire
Disease specific quality of life [4 months]
Kansas City Cardiomyopathy questionnaire
Subjective sleepiness [4 months]
Epworth sleepiness scale

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Center for Cardiology and Internal Medicine	Bishkek		Kyrgyzstan	720040

Sponsors and Collaborators

University of Zurich
National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov

Investigators

Principal Investigator: Konrad E Bloch, MD, University of Zurich, Switzerland
Principal Investigator: Talant Sooronbaev, MD, National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov