Sleep Apnea, ObstructiveNCT02051829
Comparison of Preoperative Screening Score for Obstructive Sleep Apnea (OSA)
An observational study of Sleep Apnea, Obstructive, run by Astes at 1 site in Belgium.
Trial summary
Comparison of preoperative screening score for OSA. In a preoperative population, comparison of the STOP-BANG, DES-OSA, P-SAP and OSA50 score. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep Apnea, Obstructive
- What is being tested?
- Comparison of the four screening score
- How many people
- 1,584 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2014to Apr 2016
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patients (> 18 years) presenting for preoperative assessment before surgery at SLBO.
Who may be able to join
- All adults patients (> 18 years) performing a preoperative assessment at the ASTES Doctor's Office (ASTES is an acronym with the name of Medical Doctors involved in this office)
Who cannot join
- Patients < 18 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Preoperative Screening Score for OSA
Comparison of preoperative screening score for OSA. In a preoperative population, comparison of the STOP-BANG, DES-OSA, P-SAP and OSA50 score.
Read the detailed description
Comparison of preoperative screening score for OSA (Obstructive Sleep Apnea). In a preoperative population, comparison of the STOP-BANG, DES-OSA, P-SAP and OSA50 score.
Comparison between scores and if applied with the results of a polysomnography (PSG).
- Conditions
- Sleep Apnea, Obstructive
- Being tested
- Comparison of the four screening score
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparison of the four screening scoreOther
Comparison of the four screening score, for patient making a preoperative assessment for SLBO (clinique Saint-Luc de BOuge)
| Study group | Role | What they receive |
|---|---|---|
| All patients | Comparison of the four screening score Receives: Other: Comparison of the four screening score |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with a positive DES-OSA score
Comparison of the result of the DES-OSA score with results of previously describes scores (STOP-BANG, OSA50 and P-SAP).
Measured: Baseline
Secondary outcomes (1)
Number of patients with a positive STOP-Bang score and a positive PSG (PolySomnoGraphy)
For the patients with a positive STOP-Bang score: we will make a PSG. After this one, we will compare the result of four scores (STOP-Bang, OSA50, P-SAP and DES-OSA) and the result of the PSG (especially AHI: Apnea Hypopnea Index)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 1,584 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astes
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric DEFLANDRE, MD, FCCP, Astes
- Investigators
- Eric P DEFLANDRE, MD, FCCP, Principal investigator, Astes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02051829
- Sponsor's protocol ID
- SEED-ASTES-2014
- Status last verified
- Apr 2016
- First submitted
- 24 Jan 2014
- Last updated
- 22 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Deflandre E, Degey S, Brichant JF, Donneau AF, Frognier R, Poirrier R, Bonhomme V. Pre-Operative Ability of Clinical Scores to Predict Obstructive Sleep Apnea (OSA) Severity in Susceptible Surgical Patients. Obes Surg. 2017 Mar;27(3):716-729. doi: 10.1007/s11695-016-2352-4.
PubMed 27599985
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Preoperative Screening Score for OSA
- ClinicalTrials.gov ID
- NCT02051829
- Acronym / sponsor ID
- SEED-ASTES-2014
- Conditions
- Sleep Apnea, Obstructive
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,584 participants (actual)
- Lead sponsor
- AstesUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 31 Jan 2014 (estimated)
- 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.
Comparison of preoperative screening score for OSA. In a preoperative population, comparison of the STOP-BANG, DES-OSA, P-SAP and OSA50 score.
Detailed description
Comparison of preoperative screening score for OSA (Obstructive Sleep Apnea). In a preoperative population, comparison of the STOP-BANG, DES-OSA, P-SAP and OSA50 score.
Comparison between scores and if applied with the results of a polysomnography (PSG).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients | – | Other: Comparison of the four screening scoreComparison of the four screening score |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (> 18 years) presenting for preoperative assessment before surgery at SLBO.
Key inclusion criteria (1 listed)
- All adults patients (> 18 years) performing a preoperative assessment at the ASTES Doctor's Office (ASTES is an acronym with the name of Medical Doctors involved in this office)
Key exclusion criteria (1 listed)
- Patients < 18 years
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 |
|---|---|---|
| Comparison of the four screening scoreComparison of the four screening score, for patient making a preoperative assessment for SLBO (clinique Saint-Luc de BOuge) | Other | All patients |
Primary outcome
Number of patients with a positive DES-OSA score
Time frame: Baseline
Comparison of the result of the DES-OSA score with results of previously describes scores (STOP-BANG, OSA50 and P-SAP).
1 secondary outcome
Number of patients with a positive STOP-Bang score and a positive PSG (PolySomnoGraphy)
Time frame: Baseline
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 22 Apr 2016.
- Derived from this study: PubMed 27599985Deflandre E, Degey S, Brichant JF, Donneau AF, Frognier R, Poirrier R, Bonhomme V. Pre-Operative Ability of Clinical Scores to Predict Obstructive Sleep Apnea (OSA) Severity in Susceptible Surgical Patients. Obes Surg. 2017 Mar;27(3):716-729. doi: 10.1007/s11695-016-2352-4.
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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 P DEFLANDRE, MD, FCCP 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 22 Apr 2016. 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?
Number of patients with a positive DES-OSA score (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02051829, which also lists 1 linked publication.
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 22 Apr 2016.