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Epidemiology of Sleep Disturbances Among the Adult Population of the Sao Paulo City

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Lia Azeredo-Bittencourt, Associação Fundo de Incentivo à Pesquisa
ClinicalTrials.gov Identifier:
NCT00596713
First received: January 9, 2008
Last updated: July 11, 2012
Last verified: July 2012
History of Changes
  Purpose

Sleep disturbances are of great relevance within the context of public health as they affect a sizable portion of the population with far reaching consequences. Many automobile and labor accidents as well as poor school and work performance can be traced to sleep disturbances, which are also linked to cardiovascular disease, metabolic syndrome, and psycho-cognitive alterations.

OBJECTIVES:

  1. Establish the epidemiologic profile of sleep disturbances among the adult population of the city of Sao Paulo in 2007;
  2. Investigate associations between sleep patterns and disturbances in that population, taking into account the following variables: social-demographic status, anthropometrics, clinical, activity/rest cycle, eating and physical activity habits, mood disturbances, sexual dysfunction in males, alcoholism, drug addiction, genetic markers, biochemical, hematological, endocrine, immunologic and inflammatory indicators;
  3. assess the compatibility of the results collected in the current study with those of epidemiologic sleep investigations of said city carried out in 1987 and 1995 with the aim of determining the secular sleep disturbance trend.

METHODS:

The two-stage cluster randomized sample included 1100 individuals of the city of Sao Paulo, representing the population proportionally to gender, age groups and social classes. Data were amassed as follows:

  1. the application of home and institution questionnaires;
  2. description of the sleep patterns and disturbances through polysomnography and actigraphy, performed at the Sleep Institute;
  3. collection of peripheral blood for biochemical, hematologic, endocrine and genetic assays.

STATISTICS:

Subsequent to double typing (inputting) and analysis of data consistency, descriptive and analytical statistical assessments will be performed with the aim of describing patterns of sleep disturbances associated to the explanatory variables under investigation. In the light of bi-varied analysis, predictive/explanatory multivaried models were adjusted.


Condition
Healthy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Epidemiology of Sleep Disturbances Among the Adult Population of the Sao Paulo City

Resource links provided by NLM:

MedlinePlus related topics: Sleep Disorders
U.S. FDA Resources

Further study details as provided by Associação Fundo de Incentivo à Pesquisa:

Primary Outcome Measures:
  • sleep disorders [ Time Frame: 1 night ] [ Designated as safety issue: No ]

Enrollment: 1100
Study Start Date: June 2007
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Both genders aged 20 to 80 years and living in private households in the city of São Paulo. Pregnant or lactating women, people with physical or mental impairment and workers in night shifts are not part of the population of interest.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

General population of Sao Paulo city

Criteria

Inclusion Criteria:

  • Both genders aged 20 to 80 years and living in private households in the city of São Paulo.

Exclusion Criteria:

  • Pregnant or lactating women
  • People with physical or mental impairment: and
  • Workers in night shifts.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00596713

Locations
Brazil
AFIP
Sao Paulo, Brazil, 04024-002
Sponsors and Collaborators
Associação Fundo de Incentivo à Pesquisa
Investigators
Principal Investigator: Rogerio S Silva, PhD Associacao Fundo de Incentivo a Psicofarmcologia
  More Information

No publications provided by Associação Fundo de Incentivo à Pesquisa

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Prof. Dr. Lia Azeredo-Bittencourt, Prof. Dr., Associação Fundo de Incentivo à Pesquisa
ClinicalTrials.gov Identifier: NCT00596713     History of Changes
Other Study ID Numbers: 0593/06
Study First Received: January 9, 2008
Last Updated: July 11, 2012
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Associação Fundo de Incentivo à Pesquisa:
general population

Additional relevant MeSH terms:
Sleep Disorders
Dyssomnias
Parasomnias
Nervous System Diseases
 Neurologic Manifestations
Signs and Symptoms
Mental Disorders

ClinicalTrials.gov processed this record on May 19, 2013