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Sleep Disorders and Their Cardiovascular Correlates in Atahualpa.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01877616
Recruitment Status : Completed
First Posted : June 13, 2013
Last Update Posted : November 26, 2013
Information provided by (Responsible Party):
Oscar H. Del Brutto, MD, Hospital Clínica Kennedy

Brief Summary:
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 or disease Intervention/treatment Phase
Insomnia Hypersomnia Sleep-disordered Breathing Stroke Ischemic Heart Disease Other: diagnostic test Other: Diagnostic test Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 650 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : June 2013
Actual Primary Completion Date : October 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. prevalence of sleep disorders [ Time Frame: five years ]
    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 :
  1. correlation of sleep disorders with the presence of cardiovascular risk factors, stroke, and ischemic heart disease [ Time Frame: five years ]
    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:
  1. cognitive decline [ Time Frame: five years ]
    the presence of sleep disorders will be correlated with the development of cognitive decline in the long-term follow-up

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Exclusion Criteria: persons not signing the informed consent form


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01877616

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Atahualpa, Santa Elena, Ecuador, 00000
Sponsors and Collaborators
Hospital Clínica Kennedy
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Principal Investigator: Oscar H Del Brutto, MD Universidad Espiritu Santo - Ecuador
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Responsible Party: Oscar H. Del Brutto, MD, Research Professor, Hospital Clínica Kennedy Identifier: NCT01877616    
Other Study ID Numbers: TAP-Sleep-2013
Research Department ( Other Grant/Funding Number: Universidad Espíritu Santo - Ecuador )
First Posted: June 13, 2013    Key Record Dates
Last Update Posted: November 26, 2013
Last Verified: November 2013
Keywords provided by Oscar H. Del Brutto, MD, Hospital Clínica Kennedy:
sleep disorders
sleep-disordered breathing
cardiovascular health
ischemic heart disease
Additional relevant MeSH terms:
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Respiratory Aspiration
Sleep Apnea Syndromes
Sleep Initiation and Maintenance Disorders
Sleep Wake Disorders
Disorders of Excessive Somnolence
Heart Diseases
Myocardial Ischemia
Coronary Artery Disease
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Sleep Disorders, Intrinsic
Mental Disorders
Respiration Disorders
Respiratory Tract Diseases
Neurologic Manifestations
Coronary Disease
Arterial Occlusive Diseases