Sleep Disorders and Their Cardiovascular Correlates in Atahualpa.

This study has been completed.
Information provided by (Responsible Party):
Oscar H. Del Brutto, MD, Hospital Clínica Kennedy Identifier:
First received: June 9, 2013
Last updated: November 24, 2013
Last verified: November 2013
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.

Condition Intervention
Sleep-disordered Breathing
Ischemic Heart Disease
Other: diagnostic test
Other: Diagnostic test

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Population-bases Study to Asses Prevalence of Sleep Disorders and Their Association With Cardiovascular Risk Factors and Diseases

Resource links provided by NLM:

Further study details as provided by Hospital Clínica Kennedy:

Primary Outcome Measures:
  • prevalence of sleep disorders [ Time Frame: five years ] [ Designated as safety issue: No ]
    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

Secondary Outcome Measures:
  • correlation of sleep disorders with the presence of cardiovascular risk factors, stroke, and ischemic heart disease [ Time Frame: five years ] [ Designated as safety issue: No ]
    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

Other Outcome Measures:
  • cognitive decline [ Time Frame: five years ] [ Designated as safety issue: No ]
    the presence of sleep disorders will be correlated with the development of cognitive decline in the long-term follow-up

Estimated Enrollment: 650
Study Start Date: June 2013
Study Completion Date: November 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
diagnostic test
all persons with a definitive diagnosis of a major sleep disorder (insomnia, hypersomnia, sleep-disordered breathing) will be followed annually for at least five years
Other: diagnostic test
Other: Diagnostic test
overnight polysomnography

  Show Detailed Description


Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria: all Atahualpa residents aged 40 years or more -

Exclusion Criteria: persons not signing the informed consent form

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01877616

Atahualpa, Santa Elena, Ecuador, 00000
Sponsors and Collaborators
Hospital Clínica Kennedy
Principal Investigator: Oscar H Del Brutto, MD Universidad Espiritu Santo - Ecuador
  More Information

Responsible Party: Oscar H. Del Brutto, MD, Research Professor, Hospital Clínica Kennedy Identifier: NCT01877616     History of Changes
Other Study ID Numbers: TAP-Sleep-2013  Research Department 
Study First Received: June 9, 2013
Last Updated: November 24, 2013
Health Authority: Ecuador: Ethical Committee

Keywords provided by Hospital Clínica Kennedy:
sleep disorders
sleep-disordered breathing
cardiovascular health
ischemic heart disease

Additional relevant MeSH terms:
Coronary Artery Disease
Heart Diseases
Myocardial Ischemia
Sleep Disorders
Arterial Occlusive Diseases
Cardiovascular Diseases
Coronary Disease
Mental Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Vascular Diseases processed this record on May 03, 2016