- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00989885
ESS as a Diagnosis Resource Aid of the Syndrome of Obstructive Sleep Apnea
October 5, 2009 updated by: Fortaleza University
The Effectiveness of the Epworth´s Sleepiness Scale as a Resource Aid in the Diagnosis of the Syndrome of Obstructive Sleep Apnea
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
475
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ceará
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Fortaleza, Ceará, Brazil
- Fortaleza University - Nucleus of Integrated Medical Attention
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients that sought the CESF to probable diagnosis of some sleep disorder
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Obstructive Sleep Apnea
475 patients that sought the CESF to probable diagnosis of some sleep disorder, subsequently diagnosed with Obstructive Sleep Apnea.
|
Comparison of polysomnography data records and previously made questionnaire, with the Epworth Sleepiness Scale.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Epworth's sleepiness scale
Time Frame: March 2007
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March 2007
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Polysomnography
Time Frame: May 2007
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May 2007
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2007
Primary Completion (Actual)
March 1, 2007
Study Completion (Actual)
July 1, 2007
Study Registration Dates
First Submitted
October 5, 2009
First Submitted That Met QC Criteria
October 5, 2009
First Posted (Estimate)
October 6, 2009
Study Record Updates
Last Update Posted (Estimate)
October 6, 2009
Last Update Submitted That Met QC Criteria
October 5, 2009
Last Verified
October 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FR132544
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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