Sleep Apnea, ObstructiveNCT02050685
Comparison of Different Screening Score for Hypoxemic OSA (Obstructive Sleep Apnea) With the Results of a Polysomnography (PSG)
An observational study of Sleep Apnea, Obstructive, run by Eric DEFLANDRE, MD, FCCP at 1 site in Belgium.
Trial summary
Comparison of different screening score for hypoxemic OSA (Obstructive Sleep Apnea) with the results of a polysomnography (PSG). The different screening score studied are: STOP-BANG, DES-OSA, P-SAP and OSA50. 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?
- All patients incoming in the sleep study centre for a PSG
- How many people
- 159 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2014to Dec 2015
- 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: All adults patients for an overnight polysomnography at SLBO.
Who may be able to join
- Adults patients (> 18 years)
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Different Screening Score for Hypoxemic OSA
Comparison of different screening score for hypoxemic OSA (Obstructive Sleep Apnea) with the results of a polysomnography (PSG). The different screening score studied are: STOP-BANG, DES-OSA, P-SAP and OSA50.
Read the detailed description
The investigators should compare the four screening scores (STOP-BANG, DES-OSA, P-SAP and OSA50) with the results of the PSG (and in particular the number of apnea and hypopnea index and the probability of hypoxemia).
- Conditions
- Sleep Apnea, Obstructive
- Being tested
- All patients incoming in the sleep study centre for a PSG
- 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.
All patients incoming in the sleep study centre for a PSGOther
All patients incoming in the sleep study centre for a PSG. Comparison between screening score and AHI derived from PSG.
| Study group | Role | What they receive |
|---|---|---|
| All patients for PSG at SLBO | All patients incoming in the sleep study centre for a PSG. At the arrival the screening score will be recorder. AHI will be recorded next morning after analysis of the PSG. Receives: Other: All patients incoming in the sleep study centre for a PSG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the DES-OSA score with previously described scores.
Comparison of the DES-OSA score with the results of previously described scores (STOP-BANG, P-SAP and OSA50).
Measured: The day before the PSG (PolySomnoGraphy)
Secondary outcomes (1)
Comparison of the four screening scores with results of the PSG.
Comparison of the four screening scores collected past day (before PSG - PolySomnoGraphy) with the results of the PSG (especially the AHI: Apnea Hypopnea Index)
Measured: The day after the polysomnography
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 completionDec 2015
- Study completionDec 2015
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
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eric DEFLANDRE, MD, FCCP
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Eric DEFLANDRE, MD, FCCP, Astes
- Investigators
- Eric P DEFLANDRE, MD, FCCP, Principal investigator, Astes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02050685
- Sponsor's protocol ID
- REES-ASTES-2014
- Status last verified
- Jan 2016
- First submitted
- 24 Jan 2014
- Last updated
- 6 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Deflandre E, Piette N, Bonhomme V, Degey S, Cambron L, Poirrier R, Brichant JF, Joris J. Comparison of clinical scores in their ability to detect hypoxemic severe OSA patients. PLoS One. 2018 May 7;13(5):e0196270. doi: 10.1371/journal.pone.0196270. eCollection 2018.
PubMed 29734398
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Different Screening Score for Hypoxemic OSA
- ClinicalTrials.gov ID
- NCT02050685
- Acronym / sponsor ID
- REES-ASTES-2014
- Conditions
- Sleep Apnea, Obstructive
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Eric DEFLANDRE, MD, FCCPUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (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 different screening score for hypoxemic OSA (Obstructive Sleep Apnea) with the results of a polysomnography (PSG). The different screening score studied are: STOP-BANG, DES-OSA, P-SAP and OSA50.
Detailed description
The investigators should compare the four screening scores (STOP-BANG, DES-OSA, P-SAP and OSA50) with the results of the PSG (and in particular the number of apnea and hypopnea index and the probability of hypoxemia).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients for PSG at SLBO | – | Other: All patients incoming in the sleep study centre for a PSGAll patients incoming in the sleep study centre for a PSG. At the arrival the screening score will be recorder. AHI will be recorded next morning after analysis of the PSG. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All adults patients for an overnight polysomnography at SLBO.
Key inclusion criteria (1 listed)
- Adults patients (> 18 years)
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| All patients incoming in the sleep study centre for a PSGAll patients incoming in the sleep study centre for a PSG. Comparison between screening score and AHI derived from PSG. | Other | All patients for PSG at SLBO |
Primary outcome
Comparison of the DES-OSA score with previously described scores.
Time frame: The day before the PSG (PolySomnoGraphy)
Comparison of the DES-OSA score with the results of previously described scores (STOP-BANG, P-SAP and OSA50).
1 secondary outcome
Comparison of the four screening scores with results of the PSG.
Time frame: The day after the polysomnography
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 6 Jan 2016.
- Derived from this study: PubMed 29734398Deflandre E, Piette N, Bonhomme V, Degey S, Cambron L, Poirrier R, Brichant JF, Joris J. Comparison of clinical scores in their ability to detect hypoxemic severe OSA patients. PLoS One. 2018 May 7;13(5):e0196270. doi: 10.1371/journal.pone.0196270. eCollection 2018.
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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 Eric DEFLANDRE, MD, FCCP 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 6 Jan 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?
Comparison of the DES-OSA score with previously described scores. (time frame: The day before the PSG (PolySomnoGraphy)). 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 NCT02050685, 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 6 Jan 2016.