Epidemiology of Sleep Disturbances Among the Adult Population of the Sao Paulo City
| Tracking Information | |||||
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| First Received Date ICMJE | January 9, 2008 | ||||
| Last Updated Date | July 11, 2012 | ||||
| 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 | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| 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 | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Cross-Sectional |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | General population of Sao Paulo city |
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| Condition ICMJE | Healthy | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | 1
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. |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) 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 Number ICMJE | NCT00596713 | ||||
| Other Study ID Numbers ICMJE | 0593/06 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Prof. Dr. Lia Azeredo-Bittencourt, Associação Fundo de Incentivo à Pesquisa | ||||
| Study Sponsor ICMJE | Associação Fundo de Incentivo à Pesquisa | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Associação Fundo de Incentivo à Pesquisa | ||||
| Verification Date | July 2012 | ||||
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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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