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

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.

Study Overview

• Status: Unknown
• Conditions: 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 Type: Observational
• Enrollment (Actual): 3000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Taipei Veterans General Hospital, Taiwan

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2016
• Primary Completion (ACTUAL): December 31, 2019
• Study Completion (ANTICIPATED): May 31, 2021

Study Registration Dates

• First Submitted: November 15, 2020
• First Submitted That Met QC Criteria: November 16, 2020
• First Posted (ACTUAL): November 17, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 17, 2020
• Last Update Submitted That Met QC Criteria: November 16, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea; Disorders of Excessive Somnolence; Sleepiness
• Other Study ID Numbers: 2020-09-006CC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No