Clinical trial NCT00596713: Epidemiology of Sleep Disturbances Among the Adult Population of the Sao Paulo City
Official title: Epidemiology of Sleep Disturbances Among the Adult Population of the Sao Paulo City
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: general population
Lead sponsor: Associação Fundo de Incentivo à Pesquisa
Sponsor class: OTHER
First posted: 2008-01-17
Enrollment: 1100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: General population of 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:

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.


Eligibility criteria: 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.

Primary outcomes:
measure: sleep disorders
timeFrame: 1 night
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: AFIP
Study officials:
affiliation: Associacao Fundo de Incentivo a Psicofarmcologia
name: Rogerio S Silva, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Maluly M, Dal Fabbro C, Andersen ML, Herrero Babiloni A, Lavigne GJ, Tufik S. Sleep bruxism and its associations with insomnia and OSA in the general population of Sao Paulo. Sleep Med. 2020 Nov;75:141-148. doi: 10.1016/j.sleep.2020.06.016. Epub 2020 Jun 20.
citation: Dokkedal-Silva V, Oliveira MGM, Galduroz JCF, Tufik S, Andersen ML. The effect of sleep medications on prospective and retrospective memory: a population-based study. Prog Neuropsychopharmacol Biol Psychiatry. 2021 Jan 10;104:110043. doi: 10.1016/j.pnpbp.2020.110043. Epub 2020 Jul 16.
citation: Nunes RA, Mazzotti DR, Hirotsu C, Andersen ML, Tufik S, Bittencourt L. The association between caffeine consumption and objective sleep variables is dependent on ADORA2A c.1083T>C genotypes. Sleep Med. 2017 Feb;30:210-215. doi: 10.1016/j.sleep.2016.06.038. Epub 2016 Nov 15.
citation: Roizenblatt S, Souza AL, Palombini L, Godoy LM, Tufik S, Bittencourt LR. Musculoskeletal Pain as a Marker of Health Quality. Findings from the Epidemiological Sleep Study among the Adult Population of Sao Paulo City. PLoS One. 2015 Nov 24;10(11):e0142726. doi: 10.1371/journal.pone.0142726. eCollection 2015.
citation: de Godoy LB, Palombini LO, Martinho Haddad FL, Rapoport DM, de Aguiar Vidigal T, Klichouvicz PC, Tufik S, Togeiro SM. New insights on the pathophysiology of inspiratory flow limitation during sleep. Lung. 2015 Jun;193(3):387-92. doi: 10.1007/s00408-015-9714-x. Epub 2015 Apr 1.
citation: Castro LS, Poyares D, Leger D, Bittencourt L, Tufik S. Objective prevalence of insomnia in the Sao Paulo, Brazil epidemiologic sleep study. Ann Neurol. 2013 Oct;74(4):537-46. doi: 10.1002/ana.23945. Epub 2013 Sep 16.
citation: Maluly M, Andersen ML, Dal-Fabbro C, Garbuio S, Bittencourt L, de Siqueira JT, Tufik S. Polysomnographic study of the prevalence of sleep bruxism in a population sample. J Dent Res. 2013 Jul;92(7 Suppl):97S-103S. doi: 10.1177/0022034513484328. Epub 2013 May 20.
citation: Manzotte T, Guindalini C, Mazzotti DR, Palombini L, de Souza AL, Poyares D, Bittencourt LR, Tufik S. The human leucocyte antigen DQB1*0602 allele is associated with electroencephelograph differences in individuals with obstructive sleep apnoea syndrome. J Sleep Res. 2013 Apr;22(2):217-22. doi: 10.1111/jsr.12005. Epub 2012 Nov 9.
citation: Mazzotti DR, Guindalini C, Pellegrino R, Barrueco KF, Santos-Silva R, Bittencourt LR, Tufik S. Effects of the adenosine deaminase polymorphism and caffeine intake on sleep parameters in a large population sample. Sleep. 2011 Mar 1;34(3):399-402. doi: 10.1093/sleep/34.3.399.
citation: Santos-Silva R, Bittencourt LR, Pires ML, de Mello MT, Taddei JA, Benedito-Silva AA, Pompeia C, Tufik S. Increasing trends of sleep complaints in the city of Sao Paulo, Brazil. Sleep Med. 2010 Jun;11(6):520-4. doi: 10.1016/j.sleep.2009.12.011. Epub 2010 May 21.
citation: Guindalini C, Colugnati FA, Pellegrino R, Santos-Silva R, Bittencourt LR, Tufik S. Influence of genetic ancestry on the risk of obstructive sleep apnoea syndrome. Eur Respir J. 2010 Oct;36(4):834-41. doi: 10.1183/09031936.00146809. Epub 2010 Mar 11.