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ESS as a Diagnosis Resource Aid of the Syndrome of Obstructive Sleep Apnea

This study has been completed.
Sponsor:
Collaborator:
CESF - Centro de Estudos do Sono de Fortaleza LTDA
Information provided by:
Fortaleza University
ClinicalTrials.gov Identifier:
NCT00989885
First received: October 5, 2009
Last updated: NA
Last verified: October 2009
History: No changes posted
  Purpose

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.


Condition Intervention
Sleep Apnea
Mixed Central and Obstructive Sleep Apnea
Sleep-Disordered Breathing
 Other: Questionnaire and polysomnography

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Retrospective
Official Title: The Effectiveness of the Epworth´s Sleepiness Scale as a Resource Aid in the Diagnosis of the Syndrome of Obstructive Sleep Apnea

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Fortaleza University:

Primary Outcome Measures:
  • Epworth's sleepiness scale [ Time Frame: March 2007 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Polysomnography [ Time Frame: May 2007 ] [ Designated as safety issue: Yes ]

Enrollment: 475
Study Start Date: January 2007
Study Completion Date: July 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
Comparison of polysomnography data records and previously made questionnaire, with the Epworth Sleepiness Scale.

  Eligibility

Ages Eligible for Study:   40 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • incomplete data
  • patients with concomitant diseases (heart disease, hormonal disease, chronic obstructive pulmonary disease and neurological patients)
  • patients undergoing uvulopalatopharyngoplasty
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00989885

Locations
Brazil
Fortaleza University - Nucleus of Integrated Medical Attention
Fortaleza, Ceará, Brazil
Sponsors and Collaborators
Fortaleza University
CESF - Centro de Estudos do Sono de Fortaleza LTDA
Investigators
Principal Investigator: Ingrid C Nogueira, Bachelor Fortaleza University
Study Director: Ana Cristhina O Brasil, Master Fortaleza University
Principal Investigator: Priscilla O Azevedo, Bachelor Fortaleza University
Principal Investigator: Vera Maria A Lacerda, Bachelor Fortaleza University
  More Information

No publications provided

Responsible Party: Ingrid Correia Nogueira, Fortaleza University
ClinicalTrials.gov Identifier: NCT00989885     History of Changes
Other Study ID Numbers: FR132544
Study First Received: October 5, 2009
Last Updated: October 5, 2009
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Fortaleza University:
Evaluation
Obstructive sleep apnea
Polysomnography

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Apnea
Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
 Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on May 22, 2013