Sleep Apnea, ObstructiveNCT03570580
Inter Scorers Agreement for OSA Screening Scores.
An observational study of Sleep Apnea, Obstructive, run by Astes at 1 site in Belgium.
Trial summary
Four scores are usually performed to detect OSA (Obstructive Sleep Apnea) patients. These four scores are: STOP-Bang, P-SAP, OSA50 and DES-OSA. These scores have been previously validated. However, a comparison between scorers in the realization of these scores has never been performed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea, Obstructive
- What is being tested?
- OSA scoring
- How many people
- 191 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jul 2018to 31 Dec 2018
- How long will I take part?
- 2 Months
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: For all the patients include in the study, the four scores (STOP-Bang, P-SAP, OSA50, and DES-OSA) will be performed several times by various scorers. The agreement between scorers will be statistically evaluated.
Who may be able to join
- All preoperative patients in the Cabinet Medical ASTES
Who cannot join
- Patient's refusal
Trial locations and contacts
1 site in 1 country.
About this study
Four scores are usually performed to detect OSA (Obstructive Sleep Apnea) patients. These four scores are: STOP-Bang, P-SAP, OSA50 and DES-OSA. These scores have been previously validated. However, a comparison between scorers in the realization of these scores has never been performed.
Read the detailed description
Four scores are usually performed to detect OSA (Obstructive Sleep Apnea) patients. These four scores are: STOP-Bang, P-SAP, OSA50 and DES-OSA. These scores have been previously validated. However, a comparison between scorers in the realization of these scores has never been performed. The aim of this study was to evaluate this agreement using statistical methods.
- Conditions
- Sleep Apnea, Obstructive
- Being tested
- OSA scoring
- Keywords
- Sleep Apnea, Obstructive, Mass Screening
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OSA scoringOther
OSA scoring (four scores: STOP-Bang, P-SAP, OSA50, DES-OSA were performed by several scorers on each patients, after what agreement between scores will be evaluated).
| Study group | Role | What they receive |
|---|---|---|
| Main Group - OSA Scoring | All patients include in this study for whom the four OSA scoring will be evaluated Receives: Other: OSA scoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
OSA Scoring
Should the inter-scorers agreement between OSA scoring be accurate?
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2018
- Study start1 Jul 2018
- Primary completion30 Sep 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea, ObstructiveStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 191 participants (actual)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Astes
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric DEFLANDRE, MD, PhD, FCCP, FAHA, Astes
- Investigators
- Eric Deflandre, MD, PhD, Principal investigator, Astes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03570580
- Sponsor's protocol ID
- SEED-COMP
- Status last verified
- Jun 2019
- First submitted
- 16 Jun 2018
- Last updated
- 7 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inter Scorers Agreement for OSA Screening Scores.
- ClinicalTrials.gov ID
- NCT03570580
- Acronym / sponsor ID
- SEED-COMP
- Conditions
- Sleep Apnea, Obstructive
- Keywords
- Sleep Apnea, Obstructive, Mass Screening
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 191 participants (actual)
- Lead sponsor
- AstesUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 27 Jun 2018 (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.
Four scores are usually performed to detect OSA (Obstructive Sleep Apnea) patients. These four scores are: STOP-Bang, P-SAP, OSA50 and DES-OSA. These scores have been previously validated. However, a comparison between scorers in the realization of these scores has never been performed.
Detailed description
Four scores are usually performed to detect OSA (Obstructive Sleep Apnea) patients. These four scores are: STOP-Bang, P-SAP, OSA50 and DES-OSA. These scores have been previously validated. However, a comparison between scorers in the realization of these scores has never been performed. The aim of this study was to evaluate this agreement using statistical methods.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Main Group - OSA Scoring | – | Other: OSA scoringAll patients include in this study for whom the four OSA scoring will be evaluated |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- For all the patients include in the study, the four scores (STOP-Bang, P-SAP, OSA50, and DES-OSA) will be performed several times by various scorers. The agreement between scorers will be statistically evaluated.
Key inclusion criteria (1 listed)
- All preoperative patients in the Cabinet Medical ASTES
Key exclusion criteria (1 listed)
- Patient's refusal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OSA scoringOSA scoring (four scores: STOP-Bang, P-SAP, OSA50, DES-OSA were performed by several scorers on each patients, after what agreement between scores will be evaluated). | Other | Main Group - OSA Scoring |
Primary outcome
OSA Scoring
Time frame: 2 months
Should the inter-scorers agreement between OSA scoring be accurate?
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2019.
- Individual participant dataSharing planned: Undecided. Undecided
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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.
Eric Deflandre, MD, PhD principal investigator
Astes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Apnea, Obstructive, run by Astes at 1 site in Belgium.
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 1 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: finished, as of the sponsor's last update on 7 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
OSA Scoring (time frame: 2 months). 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 7 Jun 2019.