Viewing Study NCT00596713



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Last Modification Date: 2024-10-26 @ 9:42 AM
Study NCT ID: NCT00596713
Status: COMPLETED
Last Update Posted: 2012-07-12
First Post: 2008-01-09

Brief Title: Epidemiology of Sleep Disturbances Among the Adult Population of the Sao Paulo City
Sponsor: Associação Fundo de Incentivo à Pesquisa
Organization: Associação Fundo de Incentivo à Pesquisa

Study Overview

Official Title: Epidemiology of Sleep Disturbances Among the Adult Population of the Sao Paulo City
Status: COMPLETED
Status Verified Date: 2012-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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 activityrest 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 predictiveexplanatory multivaried models were adjusted
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None