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

This study has been completed.
Sponsor:
Collaborator:
National Center for Cardiology and Internal Medicine, Bishkek, Kyrgyzstan
Information provided by (Responsible Party):
Konrad E. Bloch, University of Zurich
ClinicalTrials.gov Identifier:
NCT01621061
First received: June 13, 2012
Last updated: May 14, 2014
Last verified: May 2014

June 13, 2012
May 14, 2014
June 2012
December 2013   (final data collection date for primary outcome measure)
Sleep related breathing disturbances [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Nocturnal oxygen saturation and apnea/hypopnea index
Same as current
Complete list of historical versions of study NCT01621061 on ClinicalTrials.gov Archive Site
  • Pulmonary artery pressure [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Echocardiography
  • Dyspnea [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    NYHA functional class
  • Vigilance [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Psychomotor vigilance
  • Exercise performance [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    6 min walk test
  • Pulmonary function [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Spirometry
  • Cerebral oxygen saturation [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Near-infrared spectroscopy
  • Mountain sickness [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Quinghai chronic mountain sickness score
  • Generic quality of life [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    SF-36 quality of life questionnaire
  • Disease specific quality of life [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Kansas City Cardiomyopathy questionnaire
  • Subjective sleepiness [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Epworth sleepiness scale
  • Pulmonary artery pressure [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Echocardiography
  • Symptoms [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    NYHA functional class, Quinghai chronic mountain sickness score, SF-36 quality of life questionnaire, Kansas City Cardiomyopathy questionnaire, Epworth sleepiness scale
  • Vigilance [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Psychomotor vigilance
  • Exercise performance [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    6 min walk test
  • Pulmonary function [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Spirometry
  • Cerebral oxygen saturation [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Near-infrared spectroscopy
Not Provided
Not Provided
 
Sleep Related Breathing Disturbances and High Altitude Pulmonary Hypertension in Kyrgyz Highlanders
Sleep Apnea 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.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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.

  • High Altitude Pulmonary Hypertension
  • Sleep Apnea
Not Provided
  • High altitude pulmonary hypertension
    Highlanders with high altitude pulmonary hypertension
  • High altitude control
    Healthy highlanders
  • Low altitude control
    Healthy lowlanders
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
125
December 2013
December 2013   (final data collection date for primary outcome measure)

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
Both
16 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Kyrgyzstan
 
NCT01621061
01-7/219
No
Konrad E. Bloch, University of Zurich
University of Zurich
National Center for Cardiology and Internal Medicine, Bishkek, Kyrgyzstan
Principal Investigator: Konrad E Bloch, MD University of Zurich, Switzerland
Principal Investigator: Talant Sooronbaev, MD National Center for Cardiology and Internal Medicine, Bishkek, Kyrgyzstan
University of Zurich
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP