NCT00989885

Brief Summary

The aim of this study was to analyze the effectiveness of the Epworth's sleepiness scale as a recourse aid in the diagnosis of the syndrome of obstructive sleep apnea. 475 patients attended this study, that sought the CESF to probable diagnosis of some sleep disorder. The data were collected from records, wich are of questionnaires, including the ESE, prepared by the CESF professionals and responded, previously, by the own patients. The study compared the result obtained in the scale of Epworth with the data of polysomnography. The analysis of data was performed using the SPSS, based on descriptive and inferential statistics, being used the average considering the standard deviation, and, to the crossing of variables, was used the chi-square test of Pearson, considering as significant statistically values of p\<0.05. The results showed that gender, age and BMI are predisposing factors to SOSA.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
475

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

October 5, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 6, 2009

Completed
Last Updated

October 6, 2009

Status Verified

October 1, 2009

Enrollment Period

2 months

First QC Date

October 5, 2009

Last Update Submit

October 5, 2009

Conditions

Keywords

EvaluationObstructive sleep apneaPolysomnography

Outcome Measures

Primary Outcomes (1)

  • Epworth's sleepiness scale

    March 2007

Secondary Outcomes (1)

  • Polysomnography

    May 2007

Study Arms (1)

Obstructive Sleep Apnea

475 patients that sought the CESF to probable diagnosis of some sleep disorder, subsequently diagnosed with Obstructive Sleep Apnea.

Other: Questionnaire and polysomnography

Interventions

Comparison of polysomnography data records and previously made questionnaire, with the Epworth Sleepiness Scale.

Obstructive Sleep Apnea

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients that sought the CESF to probable diagnosis of some sleep disorder

You may qualify if:

  • Charts of whose admission of patients was from October 2005 to July 2007
  • Patients referred to the CESF for possible diagnosis of a sleep disorder

You may not qualify if:

  • incomplete data
  • patients with concomitant diseases (heart disease, hormonal disease, chronic obstructive pulmonary disease and neurological patients)
  • patients undergoing uvulopalatopharyngoplasty

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fortaleza University - Nucleus of Integrated Medical Attention

Fortaleza, Ceará, Brazil

Location

MeSH Terms

Conditions

Sleep Apnea SyndromesSleep Apnea, Obstructive

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Ingrid C Nogueira, Bachelor

    Fortaleza University

    PRINCIPAL INVESTIGATOR
  • Ana Cristhina O Brasil, Master

    Fortaleza University

    STUDY DIRECTOR
  • Priscilla O Azevedo, Bachelor

    Fortaleza University

    PRINCIPAL INVESTIGATOR
  • Vera Maria A Lacerda, Bachelor

    Fortaleza University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 5, 2009

First Posted

October 6, 2009

Study Start

January 1, 2007

Primary Completion

March 1, 2007

Study Completion

July 1, 2007

Last Updated

October 6, 2009

Record last verified: 2009-10

Locations