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OpenTrials
Completed

NCT Number: NCT00596713

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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Key information

Conditions

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

AFIP

São Paulo, 04024-002, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. sleep disorders

    Time frame: 1 night

Sponsors and collaborators

Lead sponsor

Associação Fundo de Incentivo à Pesquisa

Other

Registry information

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Jan 17, 2008
Registry last updated
Jul 12, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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