Sleep Disorders and Their Cardiovascular Correlates in Atahualpa.

NCT01877616 | Completed

• 2 other identifiers: TAP-Sleep-2013Research Department
• Study Type: interventional
• Target: 650
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia; Hypersomnia; Sleep-disordered Breathing; Stroke; Ischemic Heart Disease

Keywords

sleep disorders; insomnia; hypersomnia; sleep-disordered breathing; cardiovascular health; stroke; ischemic heart disease; Atahualpa

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• correlation of sleep disorders with the presence of cardiovascular risk factors, stroke, and ischemic heart disease

  five years

Other Outcomes (1)

• cognitive decline

  five years

Study Arms (1)

diagnostic test

OTHER

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

Interventions

Diagnostic test OTHER

Polysomnography

diagnostic test

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Hospital Clínica Kennedy: lead

Study Sites (1)

Atahualpa

Atahualpa, Santa Elena, 00000, Ecuador

Location

Related Publications (5)

• Del Brutto OH, Penaherrera E, Ochoa E, Santamaria 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.

  PMID: 23506643 BACKGROUND

• Del Brutto OH, Santamaria M, Ochoa E, Penaherrera E, Santibanez 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. No abstract available.

  PMID: 23410492 BACKGROUND

• Del Brutto OH, Tettamanti D, Del Brutto VJ, Zambrano M, Montalvan 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.

  PMID: 23733495 BACKGROUND

• Del Brutto OH, Mera RM, Costa AF, Rumbea DA, Recalde BY, Castillo PR. Long coronavirus disease-related persistent poor sleep quality and progression of enlarged perivascular spaces. A longitudinal study. Sleep. 2022 Sep 8;45(9):zsac168. doi: 10.1093/sleep/zsac168. No abstract available.

  PMID: 35878737 DERIVED

• Del Brutto OH, Mera RM, Costa AF, Recalde BY, Castillo PR. Sleep quality deterioration in middle-aged and older adults living in a rural Ecuadorian village severely struck by the SARS-CoV-2 pandemic. A population-based longitudinal prospective study. Sleep. 2021 Aug 13;44(8):zsab041. doi: 10.1093/sleep/zsab041.

  PMID: 33608714 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Disorders of Excessive Somnolence; Sleep Apnea Syndromes; Stroke; Myocardial Ischemia; Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Nervous System Diseases; Mental Disorders; Apnea; Respiration Disorders; Respiratory Tract Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Oscar H Del Brutto, MD

  Universidad Espiritu Santo - Ecuador

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Professor

Study Record Dates

• First Submitted: June 9, 2013
• First Posted: June 13, 2013
• Study Start: June 1, 2013
• Primary Completion: October 1, 2013
• Study Completion: November 1, 2013
• Last Updated: November 26, 2013

Record last verified: 2013-11

Locations

EC (1)