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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | January 9, 2008 | ||||
| Last Updated Date | January 16, 2008 | ||||
| Start Date ICMJE | June 2007 | ||||
| Primary Completion Date | December 2007 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
sleep disorders [ Time Frame: 1 night ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00596713 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Epidemiology of Sleep Disturbances Among the Adult Population of the Sao Paulo City | ||||
| Official Title ICMJE | Epidemiology of Sleep Disturbances Among the Adult Population of the Sao Paulo City | ||||
| 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:
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:
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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| Detailed Description | |||||
| Study Phase | |||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Cohort, Cross-Sectional | ||||
| Condition ICMJE | Healthy | ||||
| Intervention ICMJE | |||||
| Study Arms / Comparison Groups | 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. | ||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 1100 | ||||
| Completion Date | December 2007 | ||||
| Primary Completion Date | December 2007 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 20 Years to 80 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Brazil | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00596713 | ||||
| Responsible Party | Sergio Tufik, director, Associacao Fundo de Incentivo a Psicofarmcologia | ||||
| Study ID Numbers ICMJE | 0593/06 | ||||
| Study Sponsor ICMJE | Associacao Fundo de Incentivo a Psicofarmcologia | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Associacao Fundo de Incentivo a Psicofarmcologia | ||||
| Verification Date | January 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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