Stroke Clinical Trial
Official title:
Population-bases Study to Asses Prevalence of Sleep Disorders and Their Association With Cardiovascular Risk Factors and Diseases
Verified date | November 2013 |
Source | Hospital Clínica Kennedy |
Contact | n/a |
Is FDA regulated | No |
Health authority | Ecuador: Ethical Committee |
Study type | Interventional |
Little is known on the prevalence of sleep disorders and their role in the increased prevalence of cardiovascular diseases in the developing world. We To assess the prevalence of major sleep disorders in a rural South American population, and to determine whether these conditions are associated with a poor cardiovascular health or with the occurrence of stroke or ischemic heart disease. This is a three-phase, population-based, door-to-door survey in Atahualpa. During phase I, all residents aged ≥40 years will be screened with validated Spanish versions of five questionnaires to evaluate major sleep disorders. In phase II, neurologists will examine persons suspected of having a sleep disorder and a random sample of negative individuals to assess the prevalence of these conditions and to validate the accuracy of questionnaires. In phase III, patients with a confirmed sleep disorder will undergo nocturnal polysomnography for achieving a more specific diagnosis. The occurrence of sleep disorders will be correlated with the cardiovascular health of the population as well as with the presence of stroke and ischemic heart disease. This epidemiological study may prove cost-effective in improving sleep conditions of people living in rural areas of developing countries, and may be used as a model for the evaluation of sleep disorders and their cardiovascular correlates in these populations.
Status | Completed |
Enrollment | 650 |
Est. completion date | November 2013 |
Est. primary completion date | October 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 40 Years and older |
Eligibility |
Inclusion Criteria: all Atahualpa residents aged 40 years or more - Exclusion Criteria: persons not signing the informed consent form |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
Ecuador | Atahualpa | Atahualpa | Santa Elena |
Lead Sponsor | Collaborator |
---|---|
Hospital Clínica Kennedy |
Ecuador,
Del Brutto OH, Peñaherrera E, Ochoa E, Santamaría M, Zambrano M, Del Brutto VJ; Atahualpa Project Investigators. Door-to-door survey of cardiovascular health, stroke, and ischemic heart disease in rural coastal Ecuador--the Atahualpa Project: methodology and operational definitions. Int J Stroke. 2014 Apr;9(3):367-71. doi: 10.1111/ijs.12030. Epub 2013 Mar 19. — View Citation
Del Brutto OH, Santamaría M, Ochoa E, Peñaherrera E, Santibáñez R, Pow-Chon-Long F, Zambrano M, Del Brutto VJ. Population-based study of cardiovascular health in Atahualpa, a rural village of coastal Ecuador. Int J Cardiol. 2013 Sep 30;168(2):1618-20. doi: 10.1016/j.ijcard.2013.01.017. Epub 2013 Feb 11. — View Citation
Del Brutto OH, Tettamanti D, Del Brutto VJ, Zambrano M, Montalván M. Living alone and cardiovascular health status in residents of a rural village of coastal Ecuador (The Atahualpa Project). Environ Health Prev Med. 2013 Sep;18(5):422-5. doi: 10.1007/s12199-013-0344-8. Epub 2013 Jun 4. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | cognitive decline | the presence of sleep disorders will be correlated with the development of cognitive decline in the long-term follow-up | five years | No |
Primary | prevalence of sleep disorders | prevalence of sleep disorders will be assessed by a door-to-door survey. Then, sleep-certified specialists will move to Atahualpa to evaluate suspected persons, and positive cases will undergo polysomnography | five years | No |
Secondary | correlation of sleep disorders with the presence of cardiovascular risk factors, stroke, and ischemic heart disease | the presence of each of the major sleep disorders will be correlated with the cardiovascular status of the person as well as with the occurrence of stroke and ischemic heart disease in the follow-up | five years | No |
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