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

Completed

• Conditions: High Altitude Pulmonary Hypertension; Sleep Apnea

• Registration Number: NCT01621061
• Lead Sponsor: University of Zurich

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-06-13
• Study First Submitted QC: 2012-06-13
• Study First Posted: 2012-06-15
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-14
• Last Update Posted: 2014-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 125

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sleep related breathing disturbances	4 months	Nocturnal oxygen saturation and apnea/hypopnea index

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

National Center for Cardiology and Internal Medicine; 🇰🇬 Bishkek, Kyrgyzstan