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Completed

NCT Number: NCT01621061

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

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.

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Key information

Conditions

High Altitude Pulmonary Hypertension Apnea Cardiovascular Diseases Dyssomnias Hypertension Hypertension, Pulmonary Hypoxia Lung Diseases Nervous System Diseases Pathological Conditions, Signs and Symptoms Pulmonary edema of mountaineers Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Sleep Apnea Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders Vascular Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

National Center for Cardiology and Internal Medicine

Bishkek, 720040, Kyrgyzstan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Sleep related breathing disturbances

    Time frame: 4 months

    Nocturnal oxygen saturation and apnea/hypopnea index

Secondary outcomes

  1. Pulmonary artery pressure

    Time frame: 4 months

    Echocardiography

  2. Dyspnea

    Time frame: 4 months

    NYHA functional class

  3. Vigilance

    Time frame: 4 months

    Psychomotor vigilance

  4. Exercise performance

    Time frame: 4 months

    6 min walk test

  5. Pulmonary function

    Time frame: 4 months

    Spirometry

  6. Cerebral oxygen saturation

    Time frame: 4 months

    Near-infrared spectroscopy

  7. Mountain sickness

    Time frame: 4 months

    Quinghai chronic mountain sickness score

  8. Generic quality of life

    Time frame: 4 months

    SF-36 quality of life questionnaire

  9. Disease specific quality of life

    Time frame: 4 months

    Kansas City Cardiomyopathy questionnaire

  10. Subjective sleepiness

    Time frame: 4 months

    Epworth sleepiness scale

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Collaborators

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

Registry information

Official study title

Sleep Apnea and High Altitude Pulmonary Hypertension in Kyrgyz Highlanders

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jun 15, 2012
Registry last updated
May 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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