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

Sleep Apnea Clinical Trial

Official title:

Sleep Apnea and High Altitude Pulmonary Hypertension in Kyrgyz Highlanders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01621061
• Other study ID #: 01-7/219
• Status: Completed
• Phase: N/A
• First received: June 13, 2012
• Last updated: May 14, 2014
• Start date: June 2012
• Est. completion date: December 2013

Study information

• Verified date: May 2014
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Kyrgyzstan: Research Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Altitude Sickness
• High Altitude Pulmonary Hypertension
• Hypertension
• Hypertension, Pulmonary
• Sleep Apnea
• Sleep Apnea Syndromes

Locations

Country	Name	City	State
Kyrgyzstan	National Center for Cardiology and Internal Medicine	Bishkek

Sponsors (2)

Lead Sponsor	Collaborator
University of Zurich	National Center of Cardiology and Internal Medicine, Kyrgyzstan

Country where clinical trial is conducted

Kyrgyzstan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep related breathing disturbances	Nocturnal oxygen saturation and apnea/hypopnea index	4 months	No
Secondary	Pulmonary artery pressure	Echocardiography	4 months	No
Secondary	Dyspnea	NYHA functional class	4 months	No
Secondary	Vigilance	Psychomotor vigilance	4 months	No
Secondary	Exercise performance	6 min walk test	4 months	No
Secondary	Pulmonary function	Spirometry	4 months	No
Secondary	Cerebral oxygen saturation	Near-infrared spectroscopy	4 months	No
Secondary	Mountain sickness	Quinghai chronic mountain sickness score	4 months	No
Secondary	Generic quality of life	SF-36 quality of life questionnaire	4 months	No
Secondary	Disease specific quality of life	Kansas City Cardiomyopathy questionnaire	4 months	No
Secondary	Subjective sleepiness	Epworth sleepiness scale	4 months	No