NCT00596713

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. 1.Establish the epidemiologic profile of sleep disturbances among the adult population of the city of Sao Paulo in 2007;
  2. 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. 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.
  4. 4.the application of home and institution questionnaires;
  5. 5.description of the sleep patterns and disturbances through polysomnography and actigraphy, performed at the Sleep Institute;
  6. 6.collection of peripheral blood for biochemical, hematologic, endocrine and genetic assays.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,100

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2007

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 9, 2008

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 17, 2008

Completed
Last Updated

July 12, 2012

Status Verified

July 1, 2012

Enrollment Period

6 months

First QC Date

January 9, 2008

Last Update Submit

July 11, 2012

Conditions

Keywords

general population

Outcome Measures

Primary Outcomes (1)

  • sleep disorders

    1 night

Study Arms (1)

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.

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

General population of Sao Paulo city

You may qualify if:

  • Both genders aged 20 to 80 years and living in private households in the city of São Paulo.

You may not qualify if:

  • Pregnant or lactating women
  • People with physical or mental impairment: and
  • Workers in night shifts.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AFIP

São Paulo, São Paulo, 04024-002, Brazil

Location

Related Publications (11)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

Study Officials

  • Rogerio S Silva, PhD

    Associacao Fundo de Incentivo a Psicofarmcologia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

January 9, 2008

First Posted

January 17, 2008

Study Start

June 1, 2007

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

July 12, 2012

Record last verified: 2012-07

Locations