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AzTrials

HealthyNCT00596713

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

An observational study of Healthy, run by Associação Fundo de Incentivo à Pesquisa at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 20 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
How many people
1,100 participants
Where
1 siteBrazil
Study dates
Jun 2007to Dec 2007
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: General population of Sao Paulo city

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • AFIP

    São Paulo, São Paulo, 04024-002

Other trials in Brazil

About this study

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:

Read more
  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.

Conditions
Healthy
Keywords
general population

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00596713
Study groupRoleWhat they receive
1Both 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. sleep disorders

    Measured: 1 night

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jan 2008 (estimated)
  2. Study startJun 2007
  3. Primary completionDec 2007
  4. Study completionDec 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
1,100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00596713
Sponsor's protocol ID
0593/06
Status last verified
Jul 2012
First submitted
9 Jan 2008
Last updated
12 Jul 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 32858352

  • 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.

    PubMed 32682875

  • 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.

    PubMed 28215251

  • 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.

    PubMed 26600201

  • 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.

    PubMed 25827757

  • 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.

    PubMed 23720241

  • 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.

    PubMed 23690359

  • 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.

    PubMed 23136848

  • 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.

    PubMed 21359089

  • 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.

    PubMed 20494615

  • 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.

    PubMed 20223916

Questions about this trial

What is this clinical trial studying?

An observational study of Healthy, run by Associação Fundo de Incentivo à Pesquisa at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

sleep disorders (time frame: 1 night). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00596713, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2012.

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