Healthy Clinical Trial - Epidemiology of Sleep Disturbances Among

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00596713
Study type	Observational
Source	Associação Fundo de Incentivo à Pesquisa
Contact
Status	Completed
Phase	N/A
Start date	June 2007
Completion date	December 2007

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms