NCT04631783

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 15, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 17, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2021

Completed
Last Updated

November 17, 2020

Status Verified

November 1, 2020

Enrollment Period

4 years

First QC Date

November 15, 2020

Last Update Submit

November 16, 2020

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • 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

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2020

First Posted

November 17, 2020

Study Start

January 1, 2016

Primary Completion

December 31, 2019

Study Completion

May 31, 2021

Last Updated

November 17, 2020

Record last verified: 2020-11