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

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04631783
• Other study ID #: 2020-09-006CC
• Status: Enrolling by invitation
• Start date: January 1, 2016
• Est. completion date: May 31, 2021

Study information

• Verified date: November 2020
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 3000
• Est. completion date: May 31, 2021
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Sleepiness

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	Questionnaire: If there are some specific symptoms as a tool with better sensitivity or specificity than Epworth sleepiness scale for obstructive sleep apnea		Baseline