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

Associação Fundo de Incentivo à Pesquisa

Status: Completed

Conditions: Healthy

Study type: Observational

Funder types: Other

Identifiers

NCT00596713

0593/06

Details and patient eligibility

About

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.

Enrollment: 1,100 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

1,100 participants in 1 patient group

1

Description:

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.