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

NCT01621061 | Completed

• 1 other identifier: 01-7/219
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 1

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.

Conditions

High Altitude Pulmonary Hypertension; Sleep Apnea

Keywords

high altitude illness; pulmonary hypertension; sleep apnea; hypoxia

Outcome Measures

Primary Outcomes (1)

• Sleep related breathing disturbances

  Nocturnal oxygen saturation and apnea/hypopnea index

  4 months

Secondary Outcomes (10)

• Pulmonary artery pressure

  4 months

• Dyspnea

  4 months

• Vigilance

  4 months

• Exercise performance

  4 months

• Pulmonary function

  4 months

Study Arms (3)

High altitude pulmonary hypertension

Highlanders with high altitude pulmonary hypertension

High altitude control

Healthy highlanders

Low altitude control

Healthy lowlanders

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead
• National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov: collaborator

Study Sites (1)

National Center for Cardiology and Internal Medicine

Bishkek, 720040, Kyrgyzstan

Location

MeSH Terms

Conditions

Pulmonary edema of mountaineers; Sleep Apnea Syndromes; Hypertension, Pulmonary; Hypoxia

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Lung Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 13, 2012
• First Posted: June 15, 2012
• Study Start: June 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: May 15, 2014

Record last verified: 2014-05

Locations

KY (1)