Sleep Apnea, ObstructiveNCT03047941
Determination of Optimal Cutoff Value for Screening Severe Hypoxemic OSA (Obstructive Sleep Apnea) Patients
An observational study of Sleep Apnea, Obstructive, run by Astes at 1 site in Belgium.
Trial summary
The 4 following scores have been proposed to detect OSA (Obstructive Sleep Apnea): DES-OSA, STOP-Bang, P-SAP, and OSA50. The aim of this study is to evaluate the optimal cutoff value of these four scores to detect specifically serve OSA patients with hypoxemia. 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?
- Determination of optimal cutoff values.
- How many people
- 0 participants
- Where
- 1 siteBelgium
- Study dates
- 13 Feb 2017to 31 Oct 2022
- 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 to have a PSG in the sleep laboratory center.
Who may be able to join
- All patients scheduled to have a PSG in the sleep laboratory center.
Who cannot join
- Patients < 18 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determination of Optimal Cutoff Value of 4 Tests (DES-OSA, STOP-Bang, OSA50, P-SAP) for Screening Severe Hypoxemic OSA (Obstructive Sleep Apnea) Patients
The 4 following scores have been proposed to detect OSA (Obstructive Sleep Apnea): DES-OSA, STOP-Bang, P-SAP, and OSA50.
The aim of this study is to evaluate the optimal cutoff value of these four scores to detect specifically serve OSA patients with hypoxemia.
- Conditions
- Sleep Apnea, Obstructive
- Being tested
- Determination of optimal cutoff values.
- 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.
Determination of optimal cutoff values.Diagnostic test
The results of the four scores will be compared with the results of the polysomnography (PSG). A statistical analysis will be performed to determine the optimal cutoff value of each of the four scores to detect severe OSA patient with hypoxemia.
| Study group | Role | What they receive |
|---|---|---|
| All patients | All patients included in the present study Receives: Diagnostic Test: Determination of optimal cutoff values. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adequacy of STOP-Bang to detect severe hypoxemic OSA patients
Adequacy of STOP-Bang after comparison with the results of the PSG.
Measured: One week.
Adequacy of P-SAP to detect severe hypoxemic OSA patients
Adequacy of P-SAP after comparison with the results of the PSG.
Measured: One week
Adequacy of OSA50 to detect severe hypoxemic OSA patients
Adequacy of OSA50 after comparison with the results of the PSG.
Measured: One week
Adequacy of DES-OSA to detect severe hypoxemic OSA patients
Adequacy of DES-OSA after comparison with the results of the PSG.
Measured: One week
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 start13 Feb 2017
- Primary completion30 Sep 2022 (estimated)
- Study completion31 Oct 2022 (estimated)
Why it stopped: Lack of participants
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
- 0 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, FAHA, Astes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03047941
- Sponsor's protocol ID
- REES2
- Status last verified
- Jan 2020
- First submitted
- 6 Feb 2017
- Last updated
- 13 Jan 2020
- 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 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Optimal Cutoff Value of 4 Tests (DES-OSA, STOP-Bang, OSA50, P-SAP) for Screening Severe Hypoxemic OSA (Obstructive Sleep Apnea) Patients
- ClinicalTrials.gov ID
- NCT03047941
- Acronym / sponsor ID
- REES2
- Conditions
- Sleep Apnea, Obstructive
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Lack of participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- AstesUniversity, hospital or other
- Study start
- 13 Feb 2017 (actual)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 31 Oct 2022 (estimated)
- 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.
The 4 following scores have been proposed to detect OSA (Obstructive Sleep Apnea): DES-OSA, STOP-Bang, P-SAP, and OSA50.
The aim of this study is to evaluate the optimal cutoff value of these four scores to detect specifically serve OSA patients with hypoxemia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients | – | Diagnostic Test: Determination of optimal cutoff values.All patients included in the present study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patients scheduled to have a PSG in the sleep laboratory center.
Key inclusion criteria (1 listed)
- All patients scheduled to have a PSG in the sleep laboratory center.
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 |
|---|---|---|
| Determination of optimal cutoff values.The results of the four scores will be compared with the results of the polysomnography (PSG). A statistical analysis will be performed to determine the optimal cutoff value of each of the four scores to detect severe OSA patient with hypoxemia. | Diagnostic test | All patients |
Primary outcome
Adequacy of STOP-Bang to detect severe hypoxemic OSA patients
Time frame: One week.
Adequacy of STOP-Bang after comparison with the results of the PSG.
Adequacy of P-SAP to detect severe hypoxemic OSA patients
Time frame: One week
Adequacy of P-SAP after comparison with the results of the PSG.
Adequacy of OSA50 to detect severe hypoxemic OSA patients
Time frame: One week
Adequacy of OSA50 after comparison with the results of the PSG.
Adequacy of DES-OSA to detect severe hypoxemic OSA patients
Time frame: One week
Adequacy of DES-OSA after comparison with the results of the PSG.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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: withdrawn, as of the sponsor's last update on 13 Jan 2020. 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 was withdrawn before enrolling participants, so there are no results.
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?
Adequacy of STOP-Bang to detect severe hypoxemic OSA patients (time frame: One week.). The study lists 4 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 13 Jan 2020.