Sleep Disorders and Their Cardiovascular Correlates in Atahualpa.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Oscar H. Del Brutto, MD, Hospital Clínica Kennedy
ClinicalTrials.gov Identifier:
NCT01877616
First received: June 9, 2013
Last updated: November 24, 2013
Last verified: November 2013
  Purpose

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
Insomnia
Hypersomnia
Sleep-disordered Breathing
Stroke
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
Polysomnography
Other: Diagnostic test
overnight polysomnography

  Show Detailed Description

  Eligibility

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

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

Exclusion Criteria: persons not signing the informed consent form

-

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01877616

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

Publications:
Responsible Party: Oscar H. Del Brutto, MD, Research Professor, Hospital Clínica Kennedy
ClinicalTrials.gov 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
insomnia
hypersomnia
sleep-disordered breathing
cardiovascular health
stroke
ischemic heart disease
Atahualpa

Additional relevant MeSH terms:
Respiratory Aspiration
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Ischemia
Sleep Apnea Syndromes
Sleep Disorders
Parasomnias
Stroke
Disorders of Excessive Somnolence
Sleep Initiation and Maintenance Disorders
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes
Coronary Disease
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Apnea
Sleep Disorders, Intrinsic
Dyssomnias
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases

ClinicalTrials.gov processed this record on August 26, 2014