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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00596713
• Other study ID #: 0593/06
• Status: Completed
• Phase: N/A
• First received: January 9, 2008
• Last updated: July 11, 2012
• Start date: June 2007
• Est. completion date: December 2007

Study information

• Verified date: July 2012
• Source: Associação Fundo de Incentivo à Pesquisa
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Observational

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1100
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Dyssomnias
• Healthy
• Parasomnias
• Sleep Disorders

Locations

Country	Name	City	State
Brazil	AFIP	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Associação Fundo de Incentivo à Pesquisa

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sleep disorders		1 night	No