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

Sleep Apnea Clinical Trial

Official title:

The Effectiveness of the Epworth´s Sleepiness Scale as a Resource Aid in the Diagnosis of the Syndrome of Obstructive Sleep Apnea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00989885
• Other study ID #: FR132544
• Status: Completed
• Phase: N/A
• First received: October 5, 2009
• Last updated: October 5, 2009
• Start date: January 2007
• Est. completion date: July 2007

Study information

• Verified date: October 2009
• Source: Fortaleza University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 475
• Est. completion date: July 2007
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 60 Years

Eligibility

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 Design

Observational Model: Ecologic or Community, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Apnea
• Mixed Central and Obstructive Sleep Apnea
• Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Sleep-Disordered Breathing

Intervention

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

Locations

Country	Name	City	State
Brazil	Fortaleza University - Nucleus of Integrated Medical Attention	Fortaleza	Ceará

Sponsors (2)

Lead Sponsor	Collaborator
Fortaleza University	CESF - Centro de Estudos do Sono de Fortaleza LTDA

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Epworth's sleepiness scale		March 2007	Yes
Secondary	Polysomnography		May 2007	Yes