Sleep Apnea, ObstructiveNCT03047421
Influence of Different Methods of Measurement in the Accuracy of DES-OSA and P-SAP Scores
An observational study of Sleep Apnea, Obstructive, run by Astes at 1 site in Belgium.
Trial summary
DES-OSA and P-SAP scores have been validated to detect OSA (Obstructive Sleep Apnea). One item of P-SAP and DES-OSA is the measurement of neck circumference. The aim of this study is to compare the influence of different methods of neck circumference measurement in the accuracy of DES-OSA and P-SAP scores to detect… 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?
- Comparison of accuracy of DES-OSA and P-SAP scores
- How many people
- 1,682 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jan 2016to 31 Oct 2018
- How long will I take part?
- 1 Month
- 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
- Adult, Older adult
Study population: All patients scheduled for an anesthetic preoperative consultation
Who may be able to join
- All patients scheduled for an anesthetic preoperative consultation
Who cannot join
- < 18 years
Trial locations and contacts
1 site in 1 country.
About this study
DES-OSA and P-SAP scores have been validated to detect OSA (Obstructive Sleep Apnea).
One item of P-SAP and DES-OSA is the measurement of neck circumference. The aim of this study is to compare the influence of different methods of neck circumference measurement in the accuracy of DES-OSA and P-SAP scores to detect OSA.
- Conditions
- Sleep Apnea, Obstructive
- Being tested
- Comparison of accuracy of DES-OSA and P-SAP scores
- 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 accuracy of DES-OSA and P-SAP scoresDiagnostic test
Comparison of accuracy of DES-OSA and P-SAP scores with the result of the PSG (polysomnography)
| Study group | Role | What they receive |
|---|---|---|
| All patients included | For all patients scheduled for an anesthetic preoperative consultation, a comparison of accuracy of DES-OSA and P-SAP scores with PSG (polysomnography) will be performed. Receives: Diagnostic Test: Comparison of accuracy of DES-OSA and P-SAP scores |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of DES-OSA
Accuracy of different values of DES-OSA (due to different measurement of neck circumference) with the result of PSG.
Measured: one month
Accuracy of P-SAP
Accuracy of different values of P-SAP (due to different measurement of neck circumference) with the result of PSG.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2017 (estimated)
- Study start1 Jan 2016
- Primary completion30 Sep 2018
- Study completion31 Oct 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
- 1,682 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Astes
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric DEFLANDRE, MD, PhD, FCCP, Astes
- Investigators
- Eric DEFLANDRE, MD, FCCP, Principal investigator, Astes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03047421
- Sponsor's protocol ID
- NC-DTC
- Status last verified
- Nov 2018
- First submitted
- 7 Feb 2017
- Last updated
- 14 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Different Methods of Measurement in the Accuracy of DES-OSA and P-SAP Scores
- ClinicalTrials.gov ID
- NCT03047421
- Acronym / sponsor ID
- NC-DTC
- Conditions
- Sleep Apnea, Obstructive
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,682 participants (actual)
- Lead sponsor
- AstesUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 31 Oct 2018 (actual)
- First posted
- 9 Feb 2017 (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.
DES-OSA and P-SAP scores have been validated to detect OSA (Obstructive Sleep Apnea).
One item of P-SAP and DES-OSA is the measurement of neck circumference. The aim of this study is to compare the influence of different methods of neck circumference measurement in the accuracy of DES-OSA and P-SAP scores to detect OSA.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients included | – | Diagnostic Test: Comparison of accuracy of DES-OSA and P-SAP scoresFor all patients scheduled for an anesthetic preoperative consultation, a comparison of accuracy of DES-OSA and P-SAP scores with PSG (polysomnography) will be performed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patients scheduled for an anesthetic preoperative consultation
Key inclusion criteria (1 listed)
- All patients scheduled for an anesthetic preoperative consultation
Key exclusion criteria (1 listed)
- < 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 accuracy of DES-OSA and P-SAP scoresComparison of accuracy of DES-OSA and P-SAP scores with the result of the PSG (polysomnography) | Diagnostic test | All patients included |
Primary outcome
Accuracy of DES-OSA
Time frame: one month
Accuracy of different values of DES-OSA (due to different measurement of neck circumference) with the result of PSG.
Accuracy of P-SAP
Time frame: one month
Accuracy of different values of P-SAP (due to different measurement of neck circumference) with the result of PSG.
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 14 Nov 2018.
- Individual participant dataSharing planned: No
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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, 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 14 Nov 2018. 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?
Accuracy of DES-OSA (time frame: one month). 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 14 Nov 2018.