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

January 9, 2008
July 11, 2012
June 2007
December 2007   (final data collection date for primary outcome measure)
sleep disorders [ Time Frame: 1 night ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00596713 on ClinicalTrials.gov Archive Site
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Epidemiology of Sleep Disturbances Among the Adult Population of the Sao Paulo City
Epidemiology of Sleep Disturbances Among the Adult Population of the Sao Paulo City

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.

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Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
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Non-Probability Sample

General population of Sao Paulo city

Healthy
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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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1100
December 2007
December 2007   (final data collection date for primary outcome measure)

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.
Both
20 Years to 80 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00596713
0593/06
Yes
Prof. Dr. Lia Azeredo-Bittencourt, Associação Fundo de Incentivo à Pesquisa
Associação Fundo de Incentivo à Pesquisa
Not Provided
Principal Investigator: Rogerio S Silva, PhD Associacao Fundo de Incentivo a Psicofarmcologia
Associação Fundo de Incentivo à Pesquisa
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP