Is the Daytime Sleepiness Based on Epworth Sleepiness Scale a Good Way to Assess Taiwanese With Suspected Obstructive Sleep Apnea.

Sponsor

Taipei Veterans General Hospital, Taiwan (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT04631783

Collaborator

(none)

3,000

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This observational survey with retrospective follow-up is designed to study the daytime sleepiness based on Epworth Sleepiness Scale a good way or not to assess Taiwanese with suspected obstructive sleep apnea.

Condition or Disease	Intervention/Treatment	Phase
Obstructive Sleep Apnea

Detailed Description

Daytime sleepiness (DS) is a complicated clinical problem, often indicating a serious underlying physiological abnormality and associated with higher prevalence of comorbid conditions such as diabetes, myocardial infarction, and stroke. Daytime sleepiness is also the cardinal symptoms of obstructive sleep apnea. How to identify the high risks patients with obstructive sleep apnea for further polysomnography is a difficult problem for doctors in out-patient department. Different methods have been proposed for measuring sleepiness and the Epworth sleepiness scale (ESS) is the measure of sleepiness most commonly used in sleep research and clinical settings.

However, whether Epworth sleepiness scale is a good tool with high predictive value of obstructive sleep apnea is not evaluated in the population of Taiwanese. This observational study is set up to document these practices.

Study Design

Study Type:

Observational

Actual Enrollment :

3000 participants

Observational Model:

Case-Control

Time Perspective:

Retrospective

Official Title:

Is the Daytime Sleepiness Based on Epworth Sleepiness Scale a Good Way to Assess Taiwanese With Suspected Obstructive Sleep Apnea.

Actual Study Start Date :

Jan 1, 2016

Actual Primary Completion Date :

Dec 31, 2019

Anticipated Study Completion Date :

May 31, 2021

Outcome Measures

Primary Outcome Measures

Correlation between Epworth sleepiness scale and the severity of obstructive sleep apnea [baseline (The Epworth sleepiness scale was completed just before the polysomnography)]
use analysis to calculate the correlation
The specificity and sensitivity of Epworth sleepiness scale for obstructive sleep apnea [Baseline (The Epworth sleepiness scale was completed just before the polysomnography)]
use receiver operating characteristic curve (cut point of 10) to calculate the specificity and sensitivity

Secondary Outcome Measures

Questionnaire: If there are some specific symptoms as a tool with better sensitivity or specificity than Epworth sleepiness scale for obstructive sleep apnea [Baseline]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

patients with polysomnography during 2016/1/1-2019/12/31

Exclusion Criteria:

age under 20 year-old
incomplete polysomnography
incomplete chart information
patients with narcolepsy
patients with previous diagnosed with obstructive sleep apnea, including already patients with obstructive sleep apnea under treatment

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Taipei Veterans General Hospital, Taiwan

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Taipei Veterans General Hospital, Taiwan

ClinicalTrials.gov Identifier:

NCT04631783

Other Study ID Numbers:

2020-09-006CC

First Posted:

Nov 17, 2020

Last Update Posted:

Nov 17, 2020

Last Verified:

Nov 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Apnea

Sleep Apnea Syndromes

Sleep Apnea, Obstructive

Disorders of Excessive Somnolence

Sleepiness

Study Results

No Results Posted as of Nov 17, 2020