Obstructive Sleep ApneaNCT04631783
Is the Daytime Sleepiness Based on Epworth Sleepiness Scale a Good Way to Assess Taiwanese With Suspected Obstructive Sleep Apnea.
An observational study of Obstructive Sleep Apnea, run by Taipei Veterans General Hospital, Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea
- How many people
- 3,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 31 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with polysomnography during 2016/1/1-2019/12/31
Who may be able to join
- patients with polysomnography during 2016/1/1-2019/12/31
Who cannot join
- 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
About this study
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.
Read the 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.
- Conditions
- Obstructive Sleep Apnea
- Medical subject headings
- Sleep Apnea, Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between Epworth sleepiness scale and the severity of obstructive sleep apnea
use analysis to calculate the correlation
Measured: 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
Measured: 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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2020
- Study start1 Jan 2016
- Primary completion31 Dec 2019
- Study completion31 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 3,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04631783
- Sponsor's protocol ID
- 2020-09-006CC
- Status last verified
- Nov 2020
- First submitted
- 15 Nov 2020
- Last updated
- 17 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is the Daytime Sleepiness Based on Epworth Sleepiness Scale a Good Way to Assess Taiwanese With Suspected Obstructive Sleep Apnea.
- ClinicalTrials.gov ID
- NCT04631783
- Acronym / sponsor ID
- 2020-09-006CC
- Conditions
- Obstructive Sleep Apnea
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (actual)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 May 2021 (estimated)
- First posted
- 17 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with polysomnography during 2016/1/1-2019/12/31
Key inclusion criteria (1 listed)
- patients with polysomnography during 2016/1/1-2019/12/31
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation between Epworth sleepiness scale and the severity of obstructive sleep apnea
Time frame: 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
Time frame: 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
1 secondary outcome
Questionnaire: If there are some specific symptoms as a tool with better sensitivity or specificity than Epworth sleepiness scale for obstructive sleep apnea
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea, run by Taipei Veterans General Hospital, Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between Epworth sleepiness scale and the severity of obstructive sleep apnea (time frame: baseline (The Epworth sleepiness scale was completed just before the polysomnography)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2020.